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

Model Number	9-ITV09F45/80
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
Related manufacturer reference number: 2135147-2021-00176.On an unknown date, a 20mm amplatzer septal occluder was selected for implant using a 9f amplatzer torqvue delivery system.During procedure, as the loader was being connected to the delivery sheath, an air embolism was observed over the delivery sheath and required aspiration from the right coronary artery.The patient was transferred to the intensive care unit (icu) post-procedure.In the icu, an intracerebral event/stroke was observed and the patient was monitored.The patient was reported have been discharged in stable condition to receive rehabilitation for the stroke.
Additional Manufacturer Narrative
Additional information sections: h6, h10.An event of air embolism and stroke was 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.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11871094
• Report Number: 2135147-2021-00177
• Device Sequence Number: 804752
• Product Code: DQY
• UDI-Device Identifier: 00811806010861
• UDI-Public: 00811806010861
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 06/30/2023
• Device Model Number: 9-ITV09F45/80
• Device Catalogue Number: 9-ITV09F45/80
• Device Lot Number: 7594535
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization