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

Model Number	9-ATV07F45/60
Medical Device Problem Codes	Retraction Problem (1536); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a 12mm amplatzer septal occluder was chosen for implant using a 7f amplatzer trevisio intravascular delivery system.Prior to procedure, it was determined that the patient did not have tortuous anatomy.The device was properly flushed and prepared according to the ifu before the delivery attempt.During the procedure, the delivery cable was aligned with the disc, and the device was deployed in the patient¿s anatomy.After assessing the device position within the septum, the physician decided to retrieve the device for repositioning; however, the retrieval attempt was unsuccessful, and only the right disc could be recaptured.The physician subsequently redeployed the right disc and released the device.It was noted during the procedure that the distal tip of the delivery system was damaged.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• 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: 25861902
• Report Number: 2135147-2026-04947
• Device Sequence Number: 5558944
• Product Code: DQY
• UDI-Device Identifier: 05415067030894
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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-ATV07F45/60
• Device Catalogue Number: 9-ATV07F45/60
• Device Lot Number: 11155375
• Was Device Available for Evaluation?: No
• 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: 06/23/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• 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