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

Model Number 9-ASD-MF-025

Device Problems Material Deformation (2976); Material Protrusion/Extrusion (2979)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2020

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 25 mm amplatzer cribriform occluder was observed by transesophageal echocardiogram (tee) and fluoroscopy to have a bulbous deformation on the left atrial (la) disc during positioning.The device was removed from the patient and deployed for visual analysis and showed a protruding thread.A new 25 mm amplatzer cribriform occluder was used and was successfully implanted to resolve the event.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.The patient is currently stable with no adverse events.

Manufacturer Narrative

The reported event of a bulbous deployment and a protruding polyester thread was confirmed.Following the simulated deployment, the bulbous shape returned to normal and met functional specifications when analyzed at abbott.The polyester thread, a sewing knot met dimensional specifications when analyzed at abbott.The sewing knots that are seen above the nitinol wires are considered a normal and acceptable characteristic of the occluder.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Two capas were initiated for further investigation of the protruding threads and bulbous deformation.The investigation into the bulbous deformation did not identify a product quality issue.However, corrective actions to further enhance performance are being pursued per internal operating procedures.

• Brand Name: AMPLATZER CRIBRIFORM OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11022742
• MDR Text Key: 222409833
• Report Number: 2135147-2020-00531
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010298
• UDI-Public: 00811806010298
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• 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: 02/18/2021

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 Expiration Date: 01/31/2024
• Device Model Number: 9-ASD-MF-025
• Device Catalogue Number: 9-ASD-MF-025
• Device Lot Number: 6851256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1