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

Model Number 9-PFO-030

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method, and conclusion codes, along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2020, a 30mm amplatzer pfo occluder was selected for implant.During the procedure the device was deployed into an unusual shape.The device was removed from the patient prior to release from the delivery cable, and was exchanged for a 25mm amplatzer cribriform occluder.The 25mm cribriform was successfully implanted in the patient with no adverse events.The patient remained hemodynamically stable throughout the procedure, and there was no clinically significant delay in the procedure.

Manufacturer Narrative

The reported event of a round, bulbous deployment was confirmed.Two photos were received from the field, which appeared to show an occluder with bulbous deformation on the proximal and atrial discs.Following the simulated deployment, the bulbous shape did not return to normal and did not meet functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.A capa was initiated for further investigation and did not identify a product quality issue.However, corrective actions to further enhance performance are being pursued per internal operating procedures.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10890638
• MDR Text Key: 217993866
• Report Number: 2135147-2020-00503
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-PFO-030
• Device Lot Number: 7202945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 12/21/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1