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

Model Number	9-ATV09F45/80
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Pericardial Effusion (3271)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025 a 25-18mm amplatzer talisman pfo occluder was selected for implant using a 9f amplatzer trevisio intravascular delivery system to treat the patent foramen ovale (pfo).The patient status was in sinus rhythm.Transseptal access was through the pfo.During the procedure a circumferential pericardial effusion, which developed into a cardiac tamponade, was noted in the left atrium on the right side near the superior vena cava (svc) while manipulating the delivery system across the septum.A small nick was noted on the end of the left atrial appendage (laa).The occluder was partially re-captured once.The occluder was implanted.The pericardial effusion developed into a cardiac tamponade.A pericardiocentesis was performed and the nick was surgically repaired.The patient status was stable.
Additional Manufacturer Narrative
There was no reported device malfunction associated with the amplatzer trevisio.An event of circumferential pericardial effusion, which led to cardiac tamponade 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 defined manufacturing specifications.Based on the information received, the cause pericardial effusion could not be conclusively determined.The cause of cardiac tamponade was due to pericardial effusion.The reported surgical intervention was a result of case-specific circumstances, as surgically treated for perforation.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: 22195886
• Report Number: 2135147-2025-03113
• Device Sequence Number: 13068236
• Product Code: DQY
• UDI-Device Identifier: 05415067030931
• UDI-Public: (01)05415067030931(17)270831(10)10523342
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ATV09F45/80
• Device Catalogue Number: 9-ATV09F45/80
• Device Lot Number: 10523342
• 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: 05/20/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• 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: 25-18MM AMPLATZER TALI [9-PFO-2518, LOT: 10295023]
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male