MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. TAILOR FLEXIBLE ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number	TARP-29
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Ischemia (1942); Renal Failure (2041); Cardiovascular Dysfunction/Insufficiency (4445)
Date of Event	07/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
On (b)(6) 2017, a 29mm tailor flexible annuloplasty ring was implanted in the aortic valve position during a bicuspid aortic valve repair and ascending aorta replacement procedure in a (b)(6) year-old woman.During the procedure, the device was placed beneath the coronary ostia.The patient's left anterior descending coronary artery was injured, with the result of a massive left ventricular ischemic injury(post-operative ejection fraction of 10-15%), the need for prolonged vasopressor, ventricular assist device and cardiorespiratory support(tracheostomy), a litany of related multisystem injuries including forefoot amputations and renal failure, and the implantation of a left ventricular assist device(lvad) as a bridge to an eventual heart transplantation performed on (b)(6) 2017 at the hospital (b)(6).
Additional Manufacturer Narrative
An event of injury to the left anterior descending coronary artery and left ventricular ischemic injury 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: TAILOR FLEXIBLE ANNULOPLASTY RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 11654031
• Report Number: 2648612-2021-00036
• Device Sequence Number: 11640534
• Product Code: KRH
• UDI-Device Identifier: 05414734007696
• UDI-Public: 05414734007696
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K014161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

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: 05/02/2020
• Device Model Number: TARP-29
• Device Catalogue Number: TARP-29
• Device Lot Number: 5074421
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 05/14/2021
• 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; Life Threatening; Required Intervention
• Patient Age: 29 YR