MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Model Number	9-ITV05F180/60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: crd_1032 - sh device registry, patient site id: (b)(6).It was reported that on (b)(6) 2025, a 5-4mm amplatzer duct occluder was implanted in the patient using a 5f amplatzer torqvue delivery system.The occluder was implanted.A control echocardiogram performed immediately after device implantation in the catheterization laboratory and it was noted that the anterior valve chord rupture of tricuspid valve.The rupture occurred while advancing the delivery sheath through the tricuspid valve, most likely due to a patient¿sheath size mismatch, which led to the rupture of a chord of the anterior leaflet of the tricuspid valve.There was no intervention required.The patient is clinically stable, did not require medication despite the tricuspid regurgitation, and was discharged 24 hours after the ductus arteriosus closure 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 for patient effects of vascular dissection 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 defined manufacturing specifications.Based on the information received, the reported vascular dissection appears to be related to procedural conditions.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
Clinical information: crd_1032 - sh device registry, patient site: (b)(6).It was reported that on (b)(6) 2025, a 5-4mm amplatzer duct occluder was implanted in the patient using a 5f amplatzer torqvue delivery system.The occluder was implanted.A control echocardiogram performed immediately after device implantation in the catheterization laboratory and it was noted that the anterior valve chord rupture of tricuspid valve.The rupture occurred while advancing the delivery sheath through the tricuspid valve, most likely due to a patient¿sheath size mismatch, which led to the rupture of a chord of the anterior leaflet of the tricuspid valve.There was no intervention required.The patient is clinically stable, did not require medication despite the tricuspid regurgitation, and was discharged 24 hours after the ductus arteriosus closure procedure.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 23154864
• Report Number: 2135147-2025-05448
• Device Sequence Number: 17447545
• Product Code: DQY
• UDI-Device Identifier: 00811806010755
• UDI-Public: (01)00811806010755(17)271031(10)10625687
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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-ITV05F180/60
• Device Catalogue Number: 9-ITV05F180/60
• Device Lot Number: 10625687
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2024
• 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
• Patient Sex: Female
• Patient Weight: 3 KG