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

Model Number	9-ATV09F45/80
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Non specific EKG/ECG Changes (1817)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning for evaluation.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 9f amplatzer trevisio intravascular delivery system was selected for a patent foramen ovale (pfo) closure procedure.The patient was under conscious sedation for procedure.A standard non-abbott guidewire and soft non-abbott j guidewire were placed into the upper pulmonary vein.It was noted on a 12 lead electrocardiogram after exchanging for the delivery system, that the patient had an st elevation.Aspiration was attempted with a syringe on the leur lock of the 9f amplatzer trevisio intravascular delivery system.It's highly suspected that there was air ingress from the 9f amplatzer trevisio intravascular delivery system.There was not a continuous flush attached.The dilator and guidewires were not removed too quickly or too slowly.The loader was not immediately connected to the delivery system after the removal of the dilator or guidewire.It was also noted that patient was snoring throughout the procedure.The patient had cardiopulmonary resuscitation performed for 30 seconds, was placed on high flow oxygen, and administered unknown medication.The procedure was aborted.The patient did have a prolonged hospitalization due to this event.It's believed that the patient's extreme snoring with air entrainment contributed to the air ingress.The patient was stable at the time of report.
Additional Manufacturer Narrative
An event of air/gas in the device 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.Based on the information received, the root cause of the reported air/gas in the device results in air embolism could not be conclusively determined.It is believed that extreme snoring with air entrainment contributed to the air embolus/st elevation; however, this cannot be confirmed.The reported unexpected medical intervention was a resulted of 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
N/a.

• 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: 22350418
• Report Number: 2135147-2025-03517
• Device Sequence Number: 4772247
• Product Code: DQY
• UDI-Device Identifier: 05415067030931
• UDI-Public: (01)05415067030931(17)271130(10)10642314
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 09/12/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ATV09F45/80
• Device Catalogue Number: 9-ATV09F45/80
• Device Lot Number: 10642314
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown