MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-016

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2021

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2021, a 16 mm amplatzer septal occluder was chosen for implant, along with an 8f amplatzer¿ trevisio¿ intravascular delivery system.During procedure, the device deployed as a cobra deformation on the first and second deployment attempts.The device was then removed from the patient prior to release from the delivery cable.The device was exchanged for a new 16 mm amplatzer septal occluder, and the same delivery system was reused.The replacement device was successfully implanted to resolve this event.There was no interaction with cardiac structures during deployment.There was no angulation or kink noticed in the delivery system.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Manufacturer Narrative

The reported event of cobra deformation could not be confirmed.One photo was received from the field, which appeared to show an occluder being deployed with a cobra deformation.However, the investigation confirmed the device met visual and 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 specifications.The cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13085471
• MDR Text Key: 282776209
• Report Number: 2135147-2021-00590
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010137
• UDI-Public: 00811806010137
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

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-ASD-016
• Device Catalogue Number: 9-ASD-016
• Device Lot Number: 7436348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/24/2021
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2020
• 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