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

Catalog Number	9-ASD-020
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2024, a 22mm amplatzer septal occluder was selected for implant using a 10f amplatzer torqvue delivery system.During procedure, it could not be properly shaped and the 2 discs did not align properly.Therefore, it was exchanged for a new 24mm amplatzer septal occluder, but this device deformed into a cobra shape.Subsequently, it was exchanged for a third device and a 20mm amplatzer septal occluder was selected.However, this device failed to form correctly as the 2 discs were unable to align properly.Ultimately, no device was implanted and the procedure was not completed.None of the occluders were released from the delivery cable while inside the patient.There was no interaction with cardiac structures during deployment or angulation/kink observed with the delivery system while attempting any of the 3 occluders.The patient was safely taken off the operating table and is in stable condition.The patient remained hemodynamically stable throughout the procedure and no clinically significant prolonged procedure was reported.
Additional Manufacturer Narrative
An event of device deformity was reported.The investigation confirmed the device met functional specifications when analyzed at abbott.Information from field indicated that 10f delivery system was used.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 event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20112696
• Report Number: 2135147-2024-04309
• Device Sequence Number: 7220884
• Product Code: MLV
• UDI-Device Identifier: 00811806010175
• UDI-Public: (01)00811806010175(17)280731(10)9222950
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 9-ASD-020
• Device Lot Number: 9222950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 60 KG