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

Catalog Number	9-VSD-MUSC-014
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	07/08/2024
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 27mm navitor valve was implanted.There was no difficulty during or after valve implantation.On (b)(6) 2024, the patient had a membranous septum rupture and returned for treatment.It was believed that the cause of the ventricular membranous septum rupture was due to the annulus stent of the valve.During the ventricular septal defect closure, an arterio-venous loop was performed, and a 14mm amplatzer muscular vsd occluder was placed.The 14mm device was too small, and a large tricuspid leak appeared.The tricuspid leak was believed to be possibly due to a break in the chordae following the realization of the av loop.The 14mm device was removed, and the tricuspid regurgitation resolved.The procedure was completed with the placement of a 18mm amplatzer muscular vsd occluder using a 9f amplatzer trevisio intravascular delivery system (atv) for a satisfactory result.
Additional Manufacturer Narrative
An event of tricuspid leak was reported.A returned device assessment could not be performed as the device was not returned for analysis.It was indicated that was believed to be possibly due to a break in the chordae following the realization of the av loop.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Based on the information received, the root cause of the reported incident 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 MUSCULAR VSD 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: 20017555
• Report Number: 2135147-2024-04016
• Device Sequence Number: 12909070
• Product Code: MLV
• UDI-Device Identifier: 00811806011837
• UDI-Public: (01)00811806011837(17)271031(10)8757589
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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-VSD-MUSC-014
• Device Lot Number: 8757589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2022
• 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: AMPLATZER TREVISIO INTRAVASCULAR DS, 9-ATV09F45/80
• Patient Age: 80 YR
• Patient Sex: Unknown