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

Catalog Number	9-ATV10F45/80
Medical Device Problem Codes	Positioning Problem (3009); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
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 on (b)(6) 2024, a 24mm amplatzer septal occluder was chosen for an atrial septal defect (asd) and an atrial septal aneurysm using a 10f amplatzer trevisio intravascular delivery system.The original sizing was 20×18 mm, and a 34 mm sizing balloon was used, maximum measured size was 22 mm.Both the aortic rim and the superior rim were short, causing the left atrial (la) disc to repeatedly fall into the right atrium (ra).Attempts were made to place the device from the right pulmonary vein (pv) using a football maneuver, but it was difficult to position.After several attempts to correct the cobra head shape, the device was finally positioned, but the la disc of the cs rim fell into the ra on transesophageal echocardiography (tee), and it was poorly aligned with the aorta.When attempting to retrieve and upsize the device, the delivery cable detached and a new 12f amplatzer trevisio intravascular delivery system was chosen.A snare was used to retrieve it, but it dislodged from the septum and flew into the pv.It was noted that the 12f sheath was kinked, a new 18f non-abbott long sheath and a double snare was used for retrieval.The device was successfully retrieved, and after re-sizing, the maximum expansion was 36 mm a 38mm amplatzer septal occluder was chosen.Due to bulkiness of the device was not implanted.There was no additional product experience other than the mis-sizing on 38mm amplatzer septal occluder.A new 32mm amplatzer septal occluder was selected and successfully placed with balloon assistance.The procedure was completed successfully.There were delay in the procedure and no adverse patient effects.The patient was reported discharged.
Additional Manufacturer Narrative
An event of positioning problem and premature separation 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 incidents reported from this lot.Based on the information received, the reported positioning problem appears to be related patient conditions and procedural conditions.A cause for the reported premature separation could not be determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 21173278
• Report Number: 2135147-2025-00332
• Device Sequence Number: 11896837
• Product Code: DQY
• UDI-Device Identifier: 05415067030948
• UDI-Public: (01)05415067030948(17)260331(10)8984303
• 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): 03/06/2025

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 9-ATV10F45/80
• Device Lot Number: 8984303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2023
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 45 KG