MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER CRIBRIFORM OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Device Problems Biocompatibility (2886); Human-Device Interface Problem (2949)

Patient Problems Atrial Fibrillation (1729); Embolism (1829); Hemorrhage/Bleeding (1888); Ischemia (1942)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, out of 734 patients implanted with five different devices, 10 patients had a residual shunt, 11 had atrial fibrillation, one patient had a cerebral ischemic event, and minor bleeding and dyspepsia were also reported.200 of the 734 patients had an amplatzer cribriform implanted, but it is not known what device was implanted in the patients with the complications.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Reference manufacturing report number:2135147-2020-00258, 2135147-2020-00259, 2135147-2020-00261.The article "light anti-thrombotic regimen for prevention of device thrombosis and/or thrombotic complications after interatrial shunts device-based closure" was reviewed.This research article is a retrospective study to evaluate the long-term safety and effectiveness of a 6-month 100 mg aspirin (asa) regimen as an antiplatelet therapy after atrial septal defect (asd) or patent foramen ovale (pfo) device closure.Per the article, this regimen after asd/pfo closure appeared to be both safe and effective in preventing device thrombosis and major bleeding.There is no allegation of malfunction against the amplatzer septal occluder.The primary author of the article is gianluca rigatelli, md of section of adult and congenital heart disease, cardiovascular diagnosis and endoluminal interventions, rovigo general hospital, 45100, rovigo italy, with the corresponding email: jackyheart@libero.It.

• Brand Name: AMPLATZER CRIBRIFORM OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10131464
• MDR Text Key: 195073493
• Report Number: 2135147-2020-00260
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR