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

Model Number	9-ITV09F45/80
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Atrial Fibrillation (1729); Non specific EKG/ECG Changes (1817); Heart Block (4444)
Date of Event	02/06/2023
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 (b)(6) 2023, a 25mm amplatzer patent foramen ovale (pfo) occluder was selected for implant using a 9f amplatzer torque delivery system.The patient was consciously sedated for procedure.All components (hemostasis valve, 25mm amplatzer (pfo) occluder, loader, dilator etc.) were flushed with sterile saline as per the instructions for use.It was noted via electrocardiogram, that during procedure that the patient experienced an st elevation prior to the deployment of the left atrial disc of the occluder.The dilator had been removed slowly to prevent air ingress.There was aspiration being done prior to, or after noting the st elevation.There was no contrast injected.The patient's st elevation was treated with oxygen and an air embolism was suspected.The 25mm amplatzer patent foramen ovale (pfo) occluder was successfully implanted without difficulty.There was no leak observed/discovered in the 9f amplatzer torque delivery system.It was also noted via electrocardiogram, that during procedure the patient developed atrial fibrillation and further developed into a heart block.The decision was made to administer amiodarone in an attempt to return the patient back to a normal sinus rhythm.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure reported.Suspected air introduction is believed to be from the patient's excessive snoring, but no air embolus was confirmed.The patient was stable and recovering at the time of report.The cause of the patient's atrial fibrillation and heart block are unknown.There was no allegation of malfunction against the 25mm amplatzer (pfo) occluder, 9f amplatzer torque delivery system, or procedure.No additional information was provided.
Additional Manufacturer Narrative
An event of st elevation, atrial fibrillation, air embolism and heart block was reported.Field believed that air introduction is believed to be from the patient's excessive snoring which may have cause the reported event air embolism.Abbott requested for image of the device/issue, procedure imaging and operative notes which was not provided by the field.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 cause of the reported incident could not be conclusively determined.H6 medical device problem code: code 4062 removed.

• Brand Name: AMPLATZER TORQVUE 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: 16472703
• Report Number: 2135147-2023-00963
• Device Sequence Number: 12706400
• Product Code: DQY
• UDI-Device Identifier: 00811806010861
• UDI-Public: 00811806010861
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 05/10/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 9-ITV09F45/80
• Device Catalogue Number: 9-ITV09F45/80
• Device Lot Number: 8391976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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: Life Threatening; Other
• Patient Sex: Unknown