Real-World Experience of the MANTA Closure Device: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database

Case, Brian C.; Yerasi, Charan; Forrestal, Brian J.; Kumar, Sant; Musallam, Anees; Chezar-Azerrad, Chava; Khalid, Nauman; Shlofmitz, Evan; Khan, Jaffar; Satler, Lowell F.; Ben‐Dor, Itsik; Rogers, Toby; Waksman, Ron

doi:10.1016/j.carrev.2020.11.023

Cited by 5 publications

(5 citation statements)

References 19 publications

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“…Should we abandon suture-based VCDs in favor of the MANTA collagen plug device as the default for large-bore closure? Not based on this report alone, especially when a similar report indicated more deaths 5 occurred with the MANTA device despite fewer entries in the database. 5 However, the MANTA device may be particularly helpful in…”

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confidence: 83%

“…Not based on this report alone, especially when a similar report indicated more deaths 5 occurred with the MANTA device despite fewer entries in the database. 5 However, the MANTA device may be particularly helpful in calcified femoral arteries where suture-based VCDs are more likely to fail.Case et al 4 remind us that no device works every time in every patient. Operators must be adequately trained to minimize the risk of device failure and prepared to deal with the consequences.…”

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confidence: 99%

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confidence: 99%

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A stitch in time saves… uncontrollable blood loss

Seto

Tehrani

2021

Cathet Cardio Intervent

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Key Points Suture‐based vascular closure devices are highly effective but can fail because of operator, patient, and procedure factors. This report from the FDA MAUDE database of device failures included half where such failure led to bleeding or vascular injury requiring surgical or endovascular repair, and death in two patients. This real‐world data is limited by self‐reporting and an unclear volume of procedures but may help operators understand the failure modes and potential consequences.

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confidence: 83%

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confidence: 99%

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A stitch in time saves… uncontrollable blood loss

Seto

Tehrani

2021

Cathet Cardio Intervent

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“…From 336 articles, 21 that downloaded MAUDE data files were set aside for further analysis 11–31 . Upon manual review, 135 articles with unclear queries 32–164 and 120 with incomplete queries 165–284 were excluded. Ultimately, 60 executable queries were found 5,10,285–342 .…”

Section: Methodsmentioning

confidence: 99%

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

Li,

Feng,

Gong

et al. 2024

J Patient Saf

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Objective This article aims to assess the reproducibility of Manufacturer and User Facility Device Experience (MAUDE) data-driven studies by analyzing the data queries used in their research processes. Methods Studies using MAUDE data were sourced from PubMed by searching for “MAUDE” or “Manufacturer and User Facility Device Experience” in titles or abstracts. We manually chose articles with executable queries. The reproducibility of each query was assessed by replicating it in the MAUDE Application Programming Interface. The reproducibility of a query is determined by a reproducibility coefficient that ranges from 0.95 to 1.05. This coefficient is calculated by comparing the number of medical device reports (MDRs) returned by the reproduced queries to the number of reported MDRs in the original studies. We also computed the reproducibility ratio, which is the fraction of reproducible queries in subgroups divided by the query complexity, the device category, and the presence of a data processing flow. Results As of August 8, 2022, we identified 523 articles from which 336 contained queries, and 60 of these were executable. Among these, 14 queries were reproducible. Queries using a single field like product code, product class, or brand name showed higher reproducibility (50%, 33.3%, 31.3%) compared with other fields (8.3%, P = 0.037). Single-category device queries exhibited a higher reproducibility ratio than multicategory ones, but without statistical significance (27.1% versus 8.3%, P = 0.321). Studies including a data processing flow had a higher reproducibility ratio than those without, although this difference was not statistically significant (42.9% versus 17.4%, P = 0.107). Conclusions Our findings indicate that the reproducibility of queries in MAUDE data-driven studies is limited. Enhancing this requires the development of more effective MAUDE data query strategies and improved application programming interfaces.

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“…A commonly used closure device is the MANTA device (Teleflex, Wayne, PA, USA), which utilizes a collagen plug to achieve hemostasis after the removal of large-bore catheters. 30 When Impella support is short term, such as for high-risk PCI procedures, 2 Perclose Proglide (Abbott Vascular, Redwood City, CA, USA ) suture-mediated devices can be placed prior to Impella insertion for later closure when the device is removed.…”

Section: Removalmentioning

confidence: 99%