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

Model Number	9-ATV09F45/80
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	12/19/2022
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) 2022, a 9f amplatzer trevisio intravascular delivery system was selected for a pfo closure procedure.During the procedure, while the delivery system was in the left atrium, it was noted on transesophageal echocardiogram (tee) that there was air bubbles in the left atrium.The patients electrocardiogram (ekg) had abnormal readings.A coronarography was performed showing air in the coronary artery.The patient subsequently developed cardiac arrest.The patient was then stabilized.
Event or Problem Description
It was reported that on 19 december 2022, a 9f amplatzer trevisio intravascular delivery system was selected for a pfo closure procedure.During the procedure, while the delivery system was in the left atrium across the pfo, it was noted on transesophageal echocardiogram (tee) that there was air bubbles in the left atrium.It was observed that the bubbles were exiting the sheath tip.The patients electrocardiogram (ekg) had abnormal readings.A coronarography was performed showing air in the coronary artery.The patient subsequently developed cardiac arrest.The patient was then stabilized.The procedure was aborted and the device was not implanted.It is believed that the snoring of the patient was the cause of the air embolism.The patient is reported to be in rehabilitation.Subsequent to the previously filed report, additional information was received that the patient is reported to be in rehabilitation.The device was not implanted.It was observed that the bubbles were exiting the sheath tip.It is believed that the snoring of the patient was the cause of the air embolism.
Additional Manufacturer Narrative
An event of air embolism and cardiac arrest 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.Information from the field indicated that the device was prepared per the instructions for use, and that the patient was under conscious sedation and was snoring, which was thought to have caused the air embolism.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER TREVISIO
• 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: 16130901
• Report Number: 2135147-2023-00140
• Device Sequence Number: 3238390
• Product Code: DQY
• UDI-Device Identifier: 05415067030931
• UDI-Public: 05415067030931
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

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 Expiration Date: 02/28/2025
• Device Model Number: 9-ATV09F45/80
• Device Catalogue Number: 9-ATV09F45/80
• Device Lot Number: 8396388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• 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