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

Model Number CVD0091

Device Problems Inadequacy of Device Shape and/or Size (1583); Biocompatibility (2886)

Patient Problem Atrial Fibrillation (1729)

Event Type  Injury  

Manufacturer Narrative

A research article contained reports of amplatzer septal occluders that may be related to a report of device repositioning and atrial fibrillation post procedure.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

As reported in an article (titled - assessment of right atrial and right ventricular size in children after percutaneous closure of secundum atrial septal defect with amplatzer septal occluder), forty-two (42) children were treated with percutaneous closure of asd ii ranging from 11mm to 30 mm, in a study.It was reported that in one patient, the device was unstable and required repositioning.Another patient developed symptomatic atrial fibrillation 3 weeks after the procedure.Additional information was requested but has not been obtained.

• Brand Name: AMPLATZER SEPTAL 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: 9944960
• MDR Text Key: 187118018
• Report Number: 2135147-2020-00157
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P000039
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVD0091
• Device Catalogue Number: CVD0091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/09/2020
• 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): Other; Required Intervention