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

Model Number	9-VSD-MUSC-016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/31/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2025, a 16mm amplatzer muscular vsd occluder was chosen for a procedure using a 9f amplatzer trevisio intravascular delivery system.During preparation, it was noted that there was leak below connection to syringe and extension tubing.A new 9f amplatzer trevisio intravascular delivery system was chosen.During procedure, while deploying the device into the patient's vsd, the delivery system retracted back into the right ventricle and it was not easily observed by fluoroscopy and transesophageal echocardiography.The vsd was then advanced into the vsd but was viewed only from the right side (rv below tricuspid valve).Upon recapturing we noticed difficulty with recapturing in to the 9f delivery system and the entire system was removed.After the system was fully retracted out of the sheath in the patient's right interior jugular vein (ij vein), they noticed that there was flailing of the tricuspid valve or right papillary muscle.The case was aborted and sent to surgery with stabilizing methods in place such as extracorporeal membrane oxygenation (ecmo).The patient was taken to the surgery on the same date.On between (b)(6) 2025, patient's family declined additional procedures, impella, lava ecmo, etc.Ultimately patient passed away following emergent tricuspid valve repair post vsd repair procedure.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of patient death after the procedure due to unknown causes was reported.A returned device assessment could not be performed as the device was not returned for analysis.Field does not classify the patient death as related to the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the information received, the cause of the reported incident could be due to procedural complications (implanting difficulties).However, this cannot be conclusively determined.The reported interventions were result of case specific circumstances, as emergency cardiac surgery was performed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Based on medical review: "the patient is reported to have underlying severe tr with a vsd, and it appears that there was a technical issue with maintain the position of the delivery sheath across the vsd at the time of device deployment which inadvertently resulted in an injury to the tricuspid valve and papillary muscle following device recapture and removal.The patient acutely decompensated and required ecmo with emergency cardiac surgery which is known to have a high mortality risk.The cause of death is procedure related and not related to the device.".
Event or Problem Description
N/a.

• 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: 23649381
• Report Number: 2135147-2025-06904
• Device Sequence Number: 15966323
• Product Code: MLV
• UDI-Device Identifier: 00811806011844
• UDI-Public: (01)00811806011844(17)290630(10)10441358
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 01/20/2026

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-016
• Device Catalogue Number: 9-VSD-MUSC-016
• Device Lot Number: 10441358
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2024
• 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: Other; Death; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 80 KG