MAUDE Adverse Event Report: ABBOTT MEDICAL Amplatzer Torqvue LP; Catheter, Percutaneous

Model Number	9-TVLP4F90/060
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2026, a 4f amplatzer torqvue lp was chosen for a procedure.During procedure, a hole in the valve was noted and a valve not leak-tight.

• Brand Name: Amplatzer Torqvue LP
• 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 ; +1(651)756-5400
• MDR Report Key: 25466287
• Report Number: 2135147-2026-03933
• Device Sequence Number: 10284704
• Product Code: DQY
• UDI-Device Identifier: 00811806011561
• UDI-Public: (01)00811806011561(17)280131(10)10705817
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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-TVLP4F90/060
• Device Catalogue Number: 9-TVLP4F90/060
• Device Lot Number: 10705817
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/15/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• 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
• Patient Sex: Unknown