MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER PFO OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-PFO-035

Device Problems Retraction Problem (1536); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2018

Event Type  Injury  

Event Description

The right atrial disc of the 35 mm amplatzer pfo occluder deformed upon deployment.After a push-pull maneuver, the right atrial disc was still a little bulbous, and would not sit flat against the septum.The device was removed without complication and replaced with a second 35 mm amplatzer pfo occluder (lot: unknown) which was successfully implanted through the same 9f amplatzer torqvue 45 delivery system.It was also reported that the device was difficult to initially pull into the loader during prep.There were no known complications with this procedure.

Manufacturer Narrative

The reported event of difficulty loading the device and deformity upon deployment could not be confirmed.The investigation confirmed the device met all functional specifications when analyzed at abbott under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7904447
• MDR Text Key: 121562236
• Report Number: 2135147-2018-00162
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011301
• UDI-Public: 00811806011301
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

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 Expiration Date: 01/31/2022
• Device Model Number: 9-PFO-035
• Device Catalogue Number: 9-PFO-035
• Device Lot Number: 5858619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 09/24/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• 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