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

Model Number 9-PFO-025

Device Problems Leak/Splash (1354); Human-Device Interface Problem (2949); Material Deformation (2976)

Patient Problem Transient Ischemic Attack (2109)

Event Date 03/02/2020

Event Type  Injury  

Manufacturer Narrative

An event of "the right and left disc appearing separated and went through pfo", residual shunt 18 months after implant, and transient ischemic attack was reported.The results of the investigation are inconclusive since the device remains implanted was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On fall of 2018, a 25mm pfo was implanted to close a pfo.On release, the left and right disc appeared separated and went through the pfo.The right disc then dropped and pushed up against the aorta.On 02 march 2020, the residual shunt was still observed.The patient experience in transient ischemic attack which may be due to the pfo not fully closed.

• 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: 9886649
• MDR Text Key: 185324652
• Report Number: 2135147-2020-00136
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PFO-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2020
• 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): Hospitalization; Other