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

Catalog Number	9-ATV09F45/80
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, a 9f amplatzer trevisio delivery system (ds) was selected for use in an implant procedure.While the ds was being inserted over the wire into the vessel, the passage of the ds was impeded.The ds was removed and it was noted that the tip had became burred.It was replaced with a 10f amplatzer trevisio ds to complete the procedure.The patient remained hemodynamically stable and there was no clinically significant delay in the procedure.The patient is stable and recovering.
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 insertion into patient difficulty, and material deformation was reported.A returned device inspection, to rule out any device-related causes, 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 specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information, the cause of the reported material deformation appears to be a cascading effect of insertion difficulty.However, the cause of the insertion difficulty could not be conclusively determined.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) 2024, a 9f amplatzer trevisio delivery system (ds) was selected for use in an implant procedure.While the ds was being inserted over the wire into the vessel, the passage of the ds was impeded.The ds was removed and it was noted that the tip had became burred.It was replaced with a 10f amplatzer trevisio ds to complete the procedure.The patient remained hemodynamically stable and there was no clinically significant delay in the procedure.The patient is stable and recovering.

• 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 ; 6517565400
• MDR Report Key: 20854608
• Report Number: 2135147-2024-06133
• Device Sequence Number: 12905074
• Product Code: DQY
• UDI-Device Identifier: 05415067030931
• UDI-Public: (01)05415067030931(17)270430(10)10343256
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/18/2025

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 Catalogue Number: 9-ATV09F45/80
• Device Lot Number: 10343256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2024
• 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
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 85 KG