Long-term Outcome of Implantable Cardioverter/Defibrillator Lead Failure

Davidsson, Gustav Arnar; G, Jonsdottir; Oddsson, Hjörtur; Lund, Sigrún H.; Arnar, Davíð O.

doi:10.1001/jamainternmed.2019.4717

Cited by 5 publications

(8 citation statements)

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“…Policy makers could establish a national postmarket registry for medical devices (eg, as implemented in Iceland) and invest in programs for active surveillance (eg, as modeled by the San Francisco National Institutes of Health-funded postmortem monitoring of sudden cardiac death). 58,59 The FDA has signaled an interest in active surveillance methodologies, funding prospective studies for an active surveillance registry of implantable vascular-closure devices and supporting the National Evaluation System for health Technology (NEST). 60,61 Such platforms could help address the regulatory gaps exposed by Penumbra.…”

Section: Limits Of Postmarket Surveillancementioning

confidence: 99%

“…Improved adherence to postmarket obligations will require better processes for reporting and evaluation. Policy makers could establish a national postmarket registry for medical devices (eg, as implemented in Iceland) and invest in programs for active surveillance (eg, as modeled by the San Francisco National Institutes of Health–funded postmortem monitoring of sudden cardiac death) …”

Section: Renewing the Call For Regulatory Reformmentioning

confidence: 99%

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Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra

et al. 2022

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echanical thrombectomies, which use devices such as stentretrieversorlarge-borecatheterstoextractclotsand achieve recanalization, are an increasingly common intervention for acute ischemic stroke. In 2019, US physicians performed nearly 45 000 thrombectomies, with Penumbra, a US medical device company, manufacturing a sizeable proportion of the devices used in these procedures. 1 In January 2021, the US Food and Drug Administration (FDA) announced that the latest product from Penumbra, the JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7), was subject to a class I recall due to the risk of injury or death from the device's susceptibility to damage. 2 This designation, which is the most serious of the agency's device recalls, is applied when the FDA deems productusetobeassociatedwithareasonableprobabilityofseriousadverse health outcomes or death. 3 The FDA requested that Penumbra initi-atearecallafterreceivingmorethan200medicaldeviceadverseevent reports, including 14 deaths-likely an underestimate given that report-ing is voluntary-with the recall encompassing over 22 000 JET 7 devices in the US. 1,4 JET 7 raises several issues ranging from widespread use in patient care despite limited clinical evidence demonstrating safety and effectiveness to gaps in postmarket surveillance. These issues are familiar for medical device regulation in the US, a field which has long faced challenges regarding clinical evaluation, transparency, and oversight. 5 In this article, we present JET 7 as a case study of the need to address the gaps in US medical device regulation identified by the Institute of Medicine (IOM) in 2011 (eMethods in the Supplement). 6 Device Overview and Regulatory History Entry to MarketThe FDA cleared the first Penumbra device, the Penumbra System, in 2007, making the product only the second mechanical device IMPORTANCE Strengthening premarket and postmarket surveillance of medical devices has long been an area of focus for health policy makers. The recent class I recall (the most serious of the US Food and Drug Administration [FDA] recalls) of reperfusion catheters manufactured by Penumbra, a US-based medical device company, illustrates issues of device safety and oversight that mandate attention.OBJECTIVES To review the regulatory history and clinical evidence of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7) and use the device recall as a case study of the challenges associated with clinical evaluation, transparency, and oversight of medical devices in the US.EVIDENCE Regulatory history and clinical evidence for the Penumbra medical devices were analyzed through a qualitative review of decision letters in the Access FDA database for medical devices and medical device reports in the Manufacturer and User Facility Device Experience database and a review of market data (eg, earnings calls, company communications) and clinical literature.FINDINGS The JET 7 device was subjected to a class I recall following more than 200 adverse event reports, 14 of which involved pati...

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Section: Limits Of Postmarket Surveillancementioning

confidence: 99%

Section: Renewing the Call For Regulatory Reformmentioning

confidence: 99%

Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra

et al. 2022

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“…Despite these measures, there are increasing concerns regarding the current postmarketing surveillance system. Passive surveillance has been reported to underestimate malfunction of cardiac electronic devices that results in death . A report published by the International Consortium of Investigative Journalists estimated that nearly 2 million injuries and 80 000 deaths associated with medical devices occurred between 2008 and 2017.…”

Section: Introductionmentioning

confidence: 99%

“…Passive surveillance has been reported to underestimate malfunction of cardiac electronic devices that results in death. 6,7 A report 8 published by the International Consortium of Investigative Journalists estimated that nearly 2 million injuries and 80 000 deaths associated with medical devices occurred between 2008 and 2017. Postmarketing trials were reported to often have design limitations that hindered their ability to be of clinical use.…”

mentioning

confidence: 99%

Assessment of Data Sources That Support US Food and Drug Administration Medical Devices Safety Communications

Tau

Shepshelovich

2020

JAMA Intern Med

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Communications (MDSCs) are used by the US Food and Drug Administration (FDA) to convey important new safety information to patients and health care professionals. The sources of initial safety signals that trigger MDSCs have not been described previously.OBJECTIVE To assess the sources of initial safety signals that trigger publication of MDSCs and the potential associations among MDSC data source, type of safety issue, and subsequent FDA action. DESIGN, SETTING, AND PARTICIPANTSIn this cross-sectional study, all MDSCs published on the FDA website between January 1, 2011, and December 31, 2019, were assessed. The MDSC characteristics, sources of initiating safety signals, regulatory approval or clearance pathways of the related medical devices, and subsequent FDA actions were collected from the FDA website. MAIN OUTCOMES AND MEASURESThe main outcome was the distribution of sources of initial safety signals that led to publication of MDSCs. Secondary aims included exploration of potential associations among safety signal sources (direct reporting vs other), type of safety issue (death vs other), and FDA action (withdrawal vs other).RESULTS A total of 93 MDSCs were evaluated. Median time from device approval to MDSC posting was 10 years (interquartile range, 6-16 years). The most common data sources that triggered MDSCs were direct reports to the FDA through the Medical Device Reporting (MDR) program (44 of 93 [47%]) followed by regulator-initiated assessments (32 [34%]). Common safety issues included patient injury (25 [27%]), potential wrong diagnoses (19 [20%]), and death (18 [19%]). Frequent FDA action after MDSC posting included recommendation for increased vigilance and caution (47 [51%]), complete device withdrawal (12 [13%]), and warnings of specific lots or clinics (12 [13%]). There was a statistically significant correlation between direct reports of adverse events to the FDA through the MDR program and risk of death as a safety issue (14 of 44 [32%] for direct reporting vs 4 of 49 [8%] for any other data sources, P = .007). CONCLUSIONS AND RELEVANCEIn this cross-sectional study, the most common source of initial safety signals that triggered MDSCs was direct reports of real-world adverse events to the FDA through the MDR program. The delayed detection of postmarketing adverse events highlights the importance of proactive identification of emerging device-related safety issues.

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“…In this issue of JAMA Internal Medicine , 2 reports illustrate the importance of an improved surveillance system, particularly for life-sustaining medical devices. In one report, Davidsson et al present the nationwide experience of Iceland with the Riata defibrillator lead (St Jude Medical), which was recalled in 2011 because of the risk of serious injury or death. The study adds to prior experience about adverse events with the Riata lead .…”

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confidence: 99%

Leading the Call for Reform of Medical Device Safety Surveillance

Salazar

Redberg

2020

JAMA Intern Med

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An ideal surveillance system for medical device safety would comprehensively collect data on adverse events across the life span of a device. Preferably, the system would be integrated into electronic health records to allow seamless identification, tracking, and real-time reporting of device-associated adverse events. Moreover, it would parse adverse events to detect substantial safety signals and underperforming devices. Such a system would also allow implementation of corrective actions in a swift and commensurate manner.In this issue of JAMA Internal Medicine, 2 reports 1,2 illustrate the importance of an improved surveillance system, particularly for life-sustaining medical devices. In one report, Davidsson et al 1 present the nationwide experience of Iceland with the Riata defibrillator lead (St Jude Medical), which was recalled in 2011 because of the risk of serious injury or death. The study adds to prior experience about adverse events with the Riata lead. 3 Davidsson et al 1 used a proactive protocol to detect events, which ranged from externalization of the conductor to death, and compared these outcomes in patients with a control group of patients with other defibrillator leads. The report effectively illustrates the extent to which Riata leads underperformed; the lead failure rate was 37% (19 of 52), including 1 instance that resulted in death, compared with the 8% failure rate (4 of 50) for other defibrillator leads (hazard ratio, 4.67; 95% CI, 1.18-18.50). It is noteworthy that Iceland has exemplary record keeping; all adverse event data were captured and are available in a national registry.In another study, Sengupta et al 2 characterize the high burden of serious adverse events (including death) with another cardiac device, the InSync III model 8042 heart failure pacemaker (Medtronic). The report demonstrates considerable deficits in both the swiftness (19 months from first notice of pacemaker failure to recall) and the appropriateness of the response (the US Food and Drug Administration [FDA] classifying the recall as class II-a low probability of serious adverse events). This long unexplained delay before the recall and the inappropriate recall classification raise concerns about patient harms that could have been prevented by speedier and stronger regulatory actions.Although the characteristics of an ideal surveillance system for medical device safety are easy to state, these 2 reports demonstrate the practical challenges. The reports add to a 2015 study by Tseng et al 4 that used systematic interrogation and autopsy of sudden cardiac deaths in patients with cardiac implantable electronic devices and found that passive surveillance efforts may inaccurately estimate device malfunction. Unfortunately, cardiac devices represent the tip of

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Long-term Outcome of Implantable Cardioverter/Defibrillator Lead Failure

Cited by 5 publications

References 3 publications

Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra

Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra

Assessment of Data Sources That Support US Food and Drug Administration Medical Devices Safety Communications

Leading the Call for Reform of Medical Device Safety Surveillance

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