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

Model Number	9-ITV10F45/80
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	10/18/2021
Type of Reportable Event	Death
Event or Problem Description
This event for death is being conservatively reported.It was reported that on (b)(6) 2021, an 18 mm amplatzer p.I.Muscular vsd occluder was selected for implant, however was mis-sized as it was not stable on transesophageal echocardiogram (tee).A 20 mm amplatzer p.I.Muscular vsd occluder was then selected with a 10f amplatzer torqvue delivery system (ds), however, when deployed, the right disc showed a cobra deformation.After "several recaptures and redeployments," the issue persisted.A new 20 mm amplatzer p.I.Muscular vsd occluder was prepared to be exchanged.However, when removing the first 20 mm device with the 10f amplatzer torqvue ds, one of the tricuspid chordae was damaged, resulting in significant tricuspid regurgitation.The patient was referred to surgery and was transferred to the operating room (or) in hemodynamically stable condition.However, the patient developed heart failure after emergency surgery and failed intervention.The patient passed away the same day ((b)(6) 2021).The user did not allege a malfunction with an abbott product that lead to the patient passing.The user did not allege a relationship between the patient passing and an abbott product.No additional information was provided.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Additional Manufacturer Narrative
H6 codes updated.An event of tricuspid regurgitation caused by removing the device from the patient, and patient death due to heart failure 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
• 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: 13169353
• Report Number: 2135147-2021-00596
• Device Sequence Number: 19215818
• Product Code: DQY
• UDI-Device Identifier: 00811806010878
• UDI-Public: 00811806010878
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

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-ITV10F45/80
• Device Catalogue Number: 9-ITV10F45/80
• Device Lot Number: 7950068
• 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: 12/20/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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: Death
• Patient Sex: Unknown