Post-Market Approval Surveillance

Mehran, Roxana; Leon, Martin B.; Feigal, David; Jefferys, David; Simons, Michael; Chronos, N.; Fogarty, Thomas J.; Kuntz, Richard E.; Baim, Donald S.; Kaplan, Aaron V.

doi:10.1161/01.cir.0000134694.78653.b6

Cited by 33 publications

(20 citation statements)

References 8 publications

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“…1 However, medical device surveillance in the United States depends largely on voluntary reporting of adverse events, and, consequently, early safety signals may be missed. [2][3][4][5][6][7] Federally mandated medical device reports submitted by manufacturers to the United States Food and Drug Administration (FDA) lack denominator data and patient-specific information. 8 Determining the significance of a suspected medical device performance issue may be problematic because there are no data for comparable products.…”

mentioning

confidence: 99%

Early Detection of an Underperforming Implantable Cardiovascular Device Using an Automated Safety Surveillance Tool

Hauser

Mugglin

Friedman

et al. 2012

Circ: Cardiovascular Quality and Outcomes

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Background— Postmarket medical device surveillance in the United States depends largely on voluntary reporting of adverse events. Consequently, early safety signals may be missed, exposing patients to potentially hazardous products. The aim of this study was to assess the feasibility of using an automated safety surveillance tool to detect early signals that a marketed implantable cardiac device was underperforming. Methods and Results— For this purpose, we performed simulated prospective monthly full-cohort and propensity-matched comparative survival analyses on our 3-center database of Sprint Fidelis and Quattro Secure implantable cardioverter-defibrillator leads, using a commercially available automated surveillance tool that was preset to trigger an alert if the log rank probability value was <0.05. During the study, 84 of 1035 Fidelis (8.1%) and 23 of 1675 Quattro (1.4%) leads failed. The simulated full-cohort analysis triggered a sustained alert for Fidelis leads beginning 13 months after the first implant and 2 years before Fidelis leads were removed from the market. Of the 1035 patients who had Fidelis leads, up to 969 (93.6%) were successfully matched to Quattro patients. In the propensity-matched analysis, the alert triggered 22 months after the first Fidelis implant and more than 1 year before the lead was recalled. Conclusions— An active automated safety surveillance system could have identified this implantable cardiovascular device problem substantially sooner than was achieved through existing postmarket surveillance methods. Such a tool, when applied to clinical registries and remote monitoring databases, may limit the exposure of large populations to underperforming and potentially hazardous cardiovascular devices.

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mentioning

confidence: 99%

Early Detection of an Underperforming Implantable Cardiovascular Device Using an Automated Safety Surveillance Tool

Hauser

Mugglin

Friedman

et al. 2012

Circ: Cardiovascular Quality and Outcomes

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show abstract

“…27,28 Health care professionals use MAUDE to review events associated with specific products, body systems or procedures. [29][30][31][32][33][34] More than 120 articles referencing MAUDE have been published to date, the majority of these summarizing adverse events specific to a particular outcome, product or body system.…”

Section: The Utility Of Maudementioning

confidence: 99%

A Primer to the Structure, Content and Linkage of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) Files

Ensign¹,

Cohen²

2017

eGEMs

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“…The need for accurate, timely, and comprehensive postmarket surveillance has been highlighted by the recent introduction of drug-eluting stents into general clinical use. 2 The Second Dartmouth Device Development Symposium (3D2) held in October 2004 in Woodstock (Vt) brought together thought leaders from the major stakeholders in the medical device community, including clinical investigators, the FDA, large and small device manufacturers, and representatives from the financial community, to examine difficult issues confronting device development. Challenges surrounding postmarket surveillance of medical devices in general with a focus on interventional cardiovascular devices were examined and discussed.…”

mentioning

confidence: 99%