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

Model Number	9-ATV09F45/80
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Air Embolism (1697); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Date of Event	10/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of air bubbles in the right coronary artery and hemodynamic instability were reported.A more comprehensive 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 cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that on (b)(6) 2021, a 9 f amplatzer¿ trevisio¿ intravascular delivery system was being used for a pfo-occlusion procedure.During the procedure, the device was prepared and the delivery system was introduced into patients left atrium.The amplatzer pfo occluder was then introduced through the delivery system and pushed forward, while the left atrial disc was enfolded in the left atrium the patient started to become hemodynamically unstable (hypotension, bradycardia) with an st elevation seen on ecg.A coronary angiography was performed and small air bubbles were noted in the right coronary artery (rca) was seen.Catecholamines and adrenaline were administered due to the hemodynamic instability and the rca was flushed to remove the air bubbles.After the patient was stabilized, the procedure was continued.The delivery system and occluder were replaced for another delivery system and occluder and the implantation was completed successfully.The procedure was extended longer than is clinically significant.The patient is stable.The physician stated that during the device preparation, the amplatzer pfo occluder may not have been fully de-aired (maybe a few bubbles still remained in the nitinol-mesh).No additional information as provided.

• Brand Name: AMPLATZER¿ TREVISIO¿ INTRAVASCULAR DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12847873
• Report Number: 2135147-2021-00506
• Device Sequence Number: 11835348
• Product Code: DQY
• UDI-Device Identifier: 05415067030931
• UDI-Public: 05415067030931
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2021

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: 07/31/2024
• Device Model Number: 9-ATV09F45/80
• Device Catalogue Number: 9-ATV09F45/80
• Device Lot Number: 8082558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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