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

Catalog Number	9-ASD-034
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	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, a 34mm amplatzer septal occluder (lot: 9206144) was chosen for implantation utilizing a 12f amplatzer trevisio delivery system.During implantation, the device deformed into a cobra shape.A replacement 34mm amplatzer septal occluder (unknown lot) and replacement 12f amplatzer trevisio delivery system (unknown lot) was used to complete the procedure.There were no patient consequences or clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The reported device deformation was confirmed.The investigation at abbott confirmed the device had cobra conformation upon deployment.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The reported device deformation was determined to be a potential product quality issue.Therefore, an exception (issue) has been initiated to further investigate this complaint.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.

• 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): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19298329
• Report Number: 2135147-2024-02144
• Device Sequence Number: 6882780
• Product Code: MLV
• UDI-Device Identifier: 00811806010243
• UDI-Public: (01)00811806010243(17)280731(10)9206144
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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-034
• Device Lot Number: 9206144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 12F AMPLATZER TREVISIO DELIVERY SYSTEM.
• Patient Sex: Unknown