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

Catalog Number	9-ATV12F45/80
Medical Device Problem Codes	Positioning Problem (3009); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
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 a 34mm amplatzer septal occluder was selected for implant on(b)(6) 2024 using a 12f amplatzer trevisio intravascular delivery system to treat an atrial septal defect (asd).The diameter of the asd was measured at 27x30mm.The inferior and posterior rims were more than 5mm.The patient had a small superior rim and no aortic rim.The patient's activated clotting time (act) level was 248 seconds at the start of the procedure.During the procedure positioning was difficult and the occluder was partially re-captured multiple times.The occluder was fully re-captured and removed from the patient and deployed to confirm the occluder was still firmly attached to the delivery cable.The occluder was washed with heparinized saline.The occluder was re-loaded and re-inserted into the patient.During deployment a clot was noted on transesophageal echocardiogram (tee) while the left disc of the occluder was partially deployed.It was unknown if the clot was attached to the occluder, or the tip of the delivery sheath, or in-between both devices.Later in the procedure a thrombus was noted in the left atrial appendage (laa).It was unknown if it was the same clot that was previously noted or if a new one had formed.The procedure was aborted.Five 500 units of heparin was administered throughout the procedure.The patient's act at the end of the procedure was 300 seconds.The patient was hospitalized for monitoring and prescribed anticoagulants for the next 6 months.The patient status was stable.
Additional Manufacturer Narrative
The device was not returned for analysis.An event of patient device interaction problem (thrombosis), positioning problem, and thrombosis was reported.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 other complaints reported from this lot.The provided imaging was reviewed by an abbott clinical engineering manager.Based on all available information, a cause for the reported patient device interaction problem (thrombosis), positioning problem, and thrombosis could not be conclusively determined.The reported unexpected medical intervention and hospitalization were the result of case-specific circumstances.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.

• 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: 20928200
• Report Number: 2135147-2024-06376
• Device Sequence Number: 14713149
• Product Code: DQY
• UDI-Device Identifier: 05415067030955
• UDI-Public: (01)05415067030955(17)260630(10)9141166
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K190581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 03/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: 9-ATV12F45/80
• Device Lot Number: 9141166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2023
• 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: 34MM AMPLATZER SEPTAL OCC[9-ASD-034, LOT: 9010014]
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 44 KG