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

Model Number	9-ATV08F45/80
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2025, a 9mm amplatzer septal occluder was chosen for implant using an 8f amplatzer trevisio intravascular delivery system.During the procedure, the cobra device deformation occurred while expanding the device within the patient's anatomy.The device was removed from the patient's anatomy prior to being released from the delivery cable.A new 9mm amplatzer septal occluder was chosen using the same delivery system, a cobra device deformation occurred again.The deformed device were retrieved outside the patient prior to release from the delivery cable.It was observed that a thrombus had developed on the 8f delivery system.The thrombus did not have unusual or fiber like appearance.It was noted that the sheath was in the patient for a significant period of time due to the deformations.The activated clotting time (act) level was noted as 250 during the procedure, however it was noted that it was difficult to prolong and additional heparin was administered.The patient did not have any hematological disorders or systemic illness to contribute to the hypercoagulability.The procedure was completed using an 8mm amplatzer septal occluder and new deliver system.It was reported that there was no clinically significant delay throughout the procedure and the patient remained hemodynamically stable throughout the procedure.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of thrombus formation observed on the delivery sheath 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 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 thrombus formation could not be conclusively determined.It is possible that the unplanned prolonged procedure contributed to the reported incident; however, this cannot be confirmed.The reported serious injury/illness/impairment was a result of case-specific circumstances as no intervention was reported.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect- impact code: 4614 serious injury/ illness/ impairment.Correction: d4 - lot #, d4 - expiration date, h4 - device mfg date.

• 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: 23136450
• Report Number: 2135147-2025-05389
• Device Sequence Number: 8847114
• Product Code: DQY
• UDI-Device Identifier: 05415067030924
• UDI-Public: (01)05415067030924(17)270331(10)10295657
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/03/2025

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 Model Number: 9-ATV08F45/80
• Device Catalogue Number: 9-ATV08F45/80
• Device Lot Number: 10295657
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 18MM AMPLATZER SBII (LOT: 10763128 ,9-SB-018).; 8F TREVISIO DS (10524643,9-ATV7F45/80).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 48 KG