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

Model Number	9-ATV09F45/80
Medical Device Problem Codes	Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Date of Event	12/04/2025
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 on (b)(6) 2025, a 30-25mm amplatzer talisman pfo occluder was chosen for implant using an unknown delivery system.The initial preparation of the pfo occluder device was performed correctly, ensuring all air was removed from the loader and system.Once the device was attached and inserted into the delivery system and advanced approximately halfway through the sheath, the patient exhibited st elevations due to an air embolism.The physician retracted the device back into the loader, detached it, and removed it from the patient.On the back table, while attempting to flush and re-prepare the device, the tuohy attached to the loader did not fully seal.The technician attempted to troubleshoot the tuohy tightness; however, even when tightened as much as possible, the tuohy continued to leak saline.The procedure was completed using a new 30¿25 mm amplatzer talisman pfo occluder.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay, and no adverse effects were observed.
Additional Manufacturer Narrative
An event of air/gas in device and fluid leak was reported with non specific ekg/ecg changes and air embolism.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.There were no complaints associated with any other devices from the lot.Based on the available information, the cause for the reported air/gas in device and fluid leak could not be determined.The non specific ekg/ecg changes and air embolism are likely cascading effects from the event.The serious injury/impairment is a result from case-specific circumstances.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) 2025, a 30-25mm amplatzer talisman pfo occluder was chosen for implant using 9f amplatzer trevisio delivery system.The initial preparation of the pfo occluder device was performed correctly, ensuring all air was removed from the loader and system.Full preparation of the device was completed, including unlocking the device, de-airing the tuohy, pulling the device into the loader under saline with slow flushing, and performing multiple syringe flushes of the loader to remove all air.A wet-to-wet connection to the sheath was established with very limited bleed back out of the sheath.The device was then slowly advanced into the sheath and had not exited the sheath before st elevations were observed on the ekg by staff, the physician, and the representative, indicating an air embolism.The physician retracted the device back into the loader, detached it, and removed it from the patient.No medication was administered; the patient was treated with high-flow oxygen.The patient was under conscious sedation, and aspiration was not performed.The location of the air embolus was not confirmed, and air was not visualized.Continuous flush was not attached, and there was no leak in the delivery system.On the back table, while attempting to flush and re-prepare the device, the tuohy attached to the loader did not fully seal.The technician attempted to troubleshoot the tuohy tightness; however, even when tightened as much as possible, the tuohy continued to leak saline.The procedure was completed using a new 30¿25 mm amplatzer talisman pfo occluder.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay, and no adverse effects were observed.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay, and no adverse effects were observed.

• 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: 23927239
• Report Number: 2135147-2025-07852
• Device Sequence Number: 8825329
• Product Code: DQY
• UDI-Device Identifier: 05415067030931
• UDI-Public: (01)05415067030931(17)280531(10)10907142
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 02/09/2026

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: 10907142
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Male