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

Catalog Number	9-ATV10F45/80
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Date of Event	11/15/2023
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 15 november 2023, a 30mm amplatzer multi-fenestrated septal occluder - cribriform was chosen for an atrial septal defect (asd) case using a 10f amplatzer trevisio intravascular delivery system.During procedure, patient was under general anesthesia (ga), during the deployment of 30mm cribriform, the device had a bulbous appearance.The 30mm cribriform was re-prepared and put in the place for the second time, there was approximately 4-5 screens/ 30-45 seconds of st elevation from air in the right coronary artery (rca).The implanter suspected the cause of st elevation was air embolus and there was a persistent leak around the distal end of the device and through the device.The case of air embolus was the residual air from flushing the system.There was no intervention for the st elevation.All other vital remained stable.Patient remind hemodynamically stable and ecg (electrocardiogram) returned to normal within 1-2 minutes.During the deployment, the device had a bulbous appearance.The deformed device was never released from the delivery cable while inside the patient.There was no report of any interaction with cardiac structures during deployment.The was no report of any angulation/kink noticed with the delivery system.A new 22mm amplatzer septal occluder was chosen and implanted using the same 10f delivery system.The patient required a prolonged procedural time to complete case.The patient was reported stable and recovering.
Additional Manufacturer Narrative
An event of st elevation during the procedure suspected to be due to air embolism 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 the cause of air embolus was the residual air from flushing the system.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on 15 november 2023, a 30mm amplatzer multi-fenestrated septal cribriform occluder was chosen for an atrial septal defect (asd) case using a 10f amplatzer trevisio intravascular delivery system.During procedure, patient was under general anesthesia (ga), during the deployment of 30mm cribriform, the device had a bulbous appearance.The 30mm cribriform was re-prepared and put in the place for the second time, there was approximately 4-5 screens/ 30-45 seconds of st elevation from air in the right coronary artery (rca).The implanter suspected the cause of st elevation was air embolus and there was a persistent leak around the distal end of the device and through the device.The case of air embolus was the residual air from flushing the system.There was no intervention for the st elevation.All other vitals remained stable.Patient remained hemodynamically stable, and electrocardiogram (ecg) returned to normal within 1-2 minutes.During the deployment, the device had a bulbous appearance.The deformed device was never released from the delivery cable while inside the patient.There was no report of any interaction with cardiac structures during deployment.There was no report of any angulation/kink noticed with the delivery system.A new 22mm amplatzer septal occluder was chosen and implanted using the same 10f delivery system.The patient required a prolonged procedural time to complete case.The patient was reported stable and recovering.

• 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: 18358715
• Report Number: 2135147-2023-05582
• Device Sequence Number: 12766310
• Product Code: DQY
• UDI-Device Identifier: 05415067030948
• UDI-Public: 05415067030948
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 01/26/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 9-ATV10F45/80
• Device Lot Number: 8854677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 70 KG