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

Catalog Number	9-VSD-MUSC-012
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	01/14/2024
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 12mm amplatzer ventricular septal defect (vsd) muscular occluder was chosen for implantation utilizing a non-abbott delivery system.During deployment the device deformed into a cobra shape, so the device was removed.The device was never released from the delivery cable and did not interact with cardiac structures.The procedure ended without a replacement device.There was no patient consequences or clinically significant delay.The patient remained hemodynamically stable throughout the procedure.The patient is reported to be stable.
Additional Manufacturer Narrative
An event of device deformity during deployment was reported.The investigation confirmed the device met functional specifications when analyzed at abbott under non-physiological conditions.Information from field indicated that there was no interaction with cardiac structures during deployment and no angulation or kink in delivery system.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 MUSC VSD
• 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: 18652644
• Report Number: 2135147-2024-00525
• Device Sequence Number: 8107670
• Product Code: MLV
• UDI-Device Identifier: 00811806011820
• UDI-Public: (01)00811806011820(17)240331(10)6968612
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P040040
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 9-VSD-MUSC-012
• Device Lot Number: 6968612
• 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: 01/15/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2019
• 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 Sex: Unknown