MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER POST-INFARCT VSD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-VSDMPIHDE-018
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	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 18mm amplatzer pi musc vsd was chosen for implant using a 10f amplatzer trevisio delivery system.During the procedure, the device formed a cobra shape on the right ventricular(rv) disc.Following that, physician chose a 22mm amplatzer vascular plug ii , but the device was pulled through the defect and was removed before release from cable as the physician felt it was small for the defect.The procedure was completed using a new 24mm amplatzer pi musc vsd with satisfactory closure.It is reported that there was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout the 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 device deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.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 incident could not be conclusively determined.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2025, a 18mm amplatzer pi musc vsd was chosen for implant using a 10f amplatzer trevisio delivery system.During the procedure, the device formed a cobra shape on the right ventricular(rv) disc.Following that, physician chose a 22mm amplatzer vascular plug ii , but the device was pulled through the defect and was removed before release from cable as the physician felt it was small for the defect.The procedure was completed using a new 24mm amplatzer pi musc vsd with satisfactory closure.It is reported that there was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout the procedure.

• Brand Name: AMPLATZER POST-INFARCT 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: 23174976
• Report Number: 2135147-2025-05525
• Device Sequence Number: 9555143
• Product Code: MLV
• UDI-Device Identifier: 05415067028112
• UDI-Public: (01)05415067028112(17)270630
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 11/21/2025

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 Model Number: 9-VSDMPIHDE-018
• Device Catalogue Number: 9-VSDMPIHDE-018
• Device Lot Number: 8535531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• 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: 10FR TREVISIO (9-ATV10F45/80) WITH LOT #10811471.; 22MM AMPLATZER VASCULAR PLUG II.
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 65 KG