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

Model Number	9-ITV12F45/80
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	04/09/2022
Type of Reportable Event	Death
Event or Problem Description
This event is being reported for death due to the premature separation of the delivery system from the occluder.It was reported a 30 mm amplatzer septal occluder was chosen for procedure using an amplatzer torqvue delivery system on (b)(6) 2022.There were no issues during device preparation.During procedure, the device presented with a bulging shape and when the user attempted to remove the device, the device disconnected from the cable, embolizing into the patient's left atrium.The device did not occlude the patient's blood flow.The patient immediately became unstable.The patient went into cardiac arrest while waiting to transfer to cardiac surgery.Defibrillation efforts were made and were unsuccessful and the patient passed away.Related manufacturing reference number 2135147-2022-00252-00 (embolization of device and bulging shape).
Additional Manufacturer Narrative
An event of the occluder disconnecting from the delivery cable when attempting to recapture, cardiac arrest, and patient death was reported.A returned device assessment could not be performed as the device was not returned for analysis.One photo was received which appeared to show a deformed occluder not attached to the delivery cable within a patient.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 available information, the root cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture design or labeling.

• Brand Name: AMPLATZER TORQVUE DS
• 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: 15049657
• Report Number: 2135147-2022-00526
• Device Sequence Number: 20000470
• Product Code: DQY
• UDI-Device Identifier: 00811806010885
• UDI-Public: 00811806010885
• Combination Product (Y/N): N
• Initial Reporter Country: BG
• PMA/510(K) Number: K072313
• 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
• Report Date (Section B): 07/19/2022

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: 03/31/2024
• Device Model Number: 9-ITV12F45/80
• Device Catalogue Number: 9-ITV12F45/80
• Device Lot Number: 7929270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TORQVUE DS : 9-ITV12F45/80, 7929270
• Outcome Attributed to Adverse Event: Death
• Patient Age: 45 YR
• Patient Sex: Female