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

Model Number	9-VSD-MUSC-006
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	07/19/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2025, a 6mm amplatzer vsd muscular occluder was selected for implant.Prior to vsd procedure, an unknown sized triclip was implanted with no reported issues.The vsd occluder was implanted to close a mitral valvular leak.On (b)(6) 2025, the patient passed away due to hemolysis.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of hemolysis and death was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information, the cause of the reported incidents could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.It should be noted the per the instruction for use (ifu), ¿indications and usage: the amplatzer¿ muscular vsd occluder is indicated for use in patients with a complex ventricular septal defect (vsd) of significant size to warrant closure¿¿ codes removed: medical device problem code: 2993 adverse event without identified device or use problem.
Event or Problem Description
It was reported that on (b)(6) 2025, a 6mm amplatzer vsd muscular occluder was selected for implant.The patient's condition prior to procedure was reported as unknown.Prior to vsd procedure, an unknown sized triclip was implanted with no reported issues.The vsd occluder was implanted to close a mitral valvular leak.The patient "did well initially after the procedure, but they began to decline a couple of days later." on (b)(6) 2025, the patient passed away due to hemolysis.

• 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: 22795050
• Report Number: 2135147-2025-04495
• Device Sequence Number: 18221306
• Product Code: MLV
• UDI-Device Identifier: 00811806011790
• UDI-Public: (01)00811806011790(17)261231(10)8285048
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 11/20/2025

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 Model Number: 9-VSD-MUSC-006
• Device Catalogue Number: 9-VSD-MUSC-006
• Device Lot Number: 8285048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2022
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown