MAUDE Adverse Event Report: ABBOTT MEDICAL Amplatzer Trevisio Intravascular Delivery System; Catheter, Percutaneous

Model Number	9-ATV07F45/80
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.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 7f amplatzer trevisio delivery system was chosen for a procedure.The device was properly flushed and prepared according to the instructions for use (ifu).The patient underwent femoral access using a standard femoral introducer, followed by prior dilation using the dilator from the femoral puncture kit.The sheath had not been inspected prior to use.During insertion through the patient¿s skin in the right femoral region, resistance was encountered despite prior dilation, at which time a defect was noted.During advancement of the sheath through the femoral access, deformation of the distal end of the sheath was observed after contact with tissue along the puncture path, with small ¿teeth-like¿ deformities identified at the tip of the sheath.Device contact with the patient was limited to this initial insertion attempt, with no advancement of the system thereafter.No interaction with cardiac structures occurred, and no angulation or kinking of the delivery system was observed.To mitigate the risk of vascular complications, increased friction, potential device damage, and implant failure, the initial sheath was not used further.A second sheath of the same caliber was opened and advanced, allowing the procedure to be completed safely.There was no clinically significant delay, the patient remained hemodynamically stable throughout the procedure, and no tortuous anatomy was observed or reported.

• Brand Name: Amplatzer Trevisio Intravascular 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 ; +1(651)756-5400
• MDR Report Key: 25725137
• Report Number: 2135147-2026-04636
• Device Sequence Number: 21178518
• Product Code: DQY
• UDI-Device Identifier: 05415067030900
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K190581
• 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): 09/22/2026

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-ATV07F45/80
• Device Catalogue Number: 9-ATV07F45/80
• Device Lot Number: 10923037
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/01/2026
• 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: 06/12/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 07/06/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• 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