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

Catalog Number	9-VSD-MUSC-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemolysis (1886); Renal Failure (2041)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Literature article: "novel use of a left atrial appendage occluder for paravalvular leak closure" as reported in a research article, "novel use of a left atrial appendage occluder for paravalvular leak closure" on an unknown dare, two 10mm amplatzer muscular ventricular septal defect (vsd) occluders were implanted to close a paravalvular leak (pvl) of the unknown mechanical mitral valve in a 40-year-old male patient with obesity, diabetes mellitus, and a prior surgical mitral valve replacement procedure with an unknown mechanical valve.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Some of the post-procedural complications reported were surgical intervention, hospitalization, hemolysis, renal failure; these complications are anticipated for the procedure and subject population.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
The article, "novel use of a left atrial appendage occluder for paravalvular leak closure", was reviewed.The article presented a case study of a 40-year-old male patient with obesity, diabetes mellitus, and a prior surgical mitral valve replacement procedure with an unknown mechanical valve.It was reported that on an unknown dare, two 10mm amplatzer muscular ventricular septal defect (vsd) occluders were implanted to close a paravalvular leak (pvl) of the unknown mechanical mitral valve.It was later reported, the patient developed hemolysis, pigment nephropathy, and renal failure requiring hemodialysis.Repeat echocardiography showed moderate residual pvl between the two implanted occluders.A decision was made to explant the two vsd occluders.Subsequent attempts to close the pvl were made with a 10mm, 12mm, and 13mm amplatzer septal occluders but all devices were retrieved.A decision was made to implant a 31mm boston scientific watchman flx occluder to treat the pvl.Several coils, two 10x35mm penumbra ruby and one 8 x40mm penumbra 400, were additionally implanted to minimize embolization of the occluder.[the primary and corresponding author was james mccabe, division of cardiology, department of medicine, university of washington, seattle, washington, with corresponding email: jmmccabe@cardiology.Washington.Edu].

• 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: 18955435
• Report Number: 2135147-2024-01311
• Device Sequence Number: 17278310
• Product Code: MLV
• UDI-Device Identifier: 00811806011813
• UDI-Public: 00811806011813
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9-VSD-MUSC-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 40 YR
• Patient Sex: Male