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

Device Problems Malposition of Device (2616); Material Split, Cut or Torn (4008)

Patient Problem Chest Pain (1776)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, over a period of 9 years 9,109 amplatzer devices were implanted, of those 19 were explanted.Five of the devices were explanted due to residual shunt; of these four had evidence of malposition of the device or a new atrial tear and two patients experienced chest pain.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Reference manufacturing report number:2135147-2019-00390, 2135147-2019-00389, 2135147-2019-00388, 2135147-2019-00386, 2135147-2019-00383, 2135147-2019-00382, 2135147-2019-00381.It was reported through a research article identifying amplatzer that may be related to explant of devices.Specific patient information is documented as unknown.Details are listed in the attached article, titled explantation of patent foramen ovale closure devices.A study was conducted on the explantation of patent foramen ovale (pfo) devices over a course of nine years.It was found that of the 9,109 amplatzer devices were implanted and 19 were explanted.Five of the devices that were explanted were due to residual shunts.Two of the patients experienced chest pains.There were indications of device malposition or new atrial tear in four of the patients.No patient consequences were reported post procedure.

• Brand Name: AMPLATZER PFO 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: 9345063
• MDR Text Key: 169321490
• Report Number: 2135147-2019-00384
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 11/11/2019
• 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