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

Catalog Number	9-ATV08F45/80
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Bradycardia (1751); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)
Date of Event	07/03/2024
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 a 16mm amplatzer septal occluder was selected for implant on (b)(6) 2024 using a 8f amplatzer trevisio intravascular delivery system.The patient was under conscious sedation.During the procedure the delivery system was aspirated prior to insertion of the occluder.The continuous flush was attached to the y-port of the delivery system.During implant the left atrial disc of the device took on a cobra shape.During re-deployment the patient experienced an st elevation, followed by bradycardia and a drop in blood pressure.Adrenalin and atropine were administered.The patient re-stabilized within 5 minutes.The device was re-captured and re-deployed but the cobra shape persisted.The device was removed from the patient and replaced with a new 17mm amplatzer septal occluder.There were no interactions with cardiac structures.There were no angulations or kinks noted on the delivery system.No leaks were observed.The physician suspected an air embolism caused the st elevation.No air was visualized in the patient, however low left atrial pressure and advancing air into the patient's heart along with the device was attributed to the air embolism.The patient status was stable.
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.Information from the field indicated that during the procedure the delivery system was aspirated prior to insertion of the occluder.The continuous flush was attached to the y-port of the delivery system.During re-deployment, the patient experienced an st elevation, followed by bradycardia and a drop in blood pressure.Medications were administered and the patient re-stabilized.The device was re-captured and re-deployed but the cobra shape persisted.The device was removed from the patient and replaced with a new amplatzer septal occluder.No leaks were observed.The physician suspected an air embolism caused the st elevation.No air was visualized in the patient, however low left atrial pressure and advancing air into the patient's heart along with the device was attributed to the air embolism.Based on the information received, the root cause of the reported air/gas in the device could not be conclusively determined.The reported patient effects of air embolism appear to be related to the reported air in the device.The reported patient effects of non specific ekg/ecg changes (st elevation) was cascading event of the air embolism.The reported patient effects of bradycardia and low blood pressure are related to the ekg/ecg changes.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.

• 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: 19841758
• Report Number: 2135147-2024-03645
• Device Sequence Number: 20482554
• Product Code: DQY
• UDI-Device Identifier: 05415067030924
• UDI-Public: (01)05415067030924(17)250930(10)8704059
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/21/2024

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: 09/30/2025
• Device Catalogue Number: 9-ATV08F45/80
• Device Lot Number: 8704059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER SEPTAL OCCLUDER [9-ASD-016, LOT 8585103]
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown