MAUDE Adverse Event Report: ABBOTT MEDICAL REGENT HEART VALVE WITH FLEX CUFF; HEART-VALVE, MECHANICAL

Catalog Number	19AGFN-756
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/17/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
B2 - date of death is estimated.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 17 october 2023, a 21mm regent valve was chosen for implantation.Once implanted, the valve leaflets would not open or close when testing the valve.It was reported that it was possible that the valve was oversized.The 21mm regent was removed, and a replacement 19mm regent valve was implanted successfully.At the end of the procedure, the patient had difficulty being removed from cardiopulmonary bypass (cpb).The patient was placed on an impella device.After the procedure, the patient was transferred to a different hospital.On an unknown date, the patient died due to an unknown cause.The physician thought it was unrelated to the valve and that it was possibly due to undiagnosed pulmonary hypertension.
Additional Manufacturer Narrative
An event of patient having difficulty being removed from cardiopulmonary bypass after procedure and patient death was reported.It was reported that a 21 mm regent valve was implanted that would not open or close and a decision was made to downsize to a 19 mm regent valve.The patient had difficulty coming off cardiopulmonary bypass and needed a temporary lvad with an impella device.A returned device assessment and histopathological examination could not be performed as the device remained implanted and was not returned for analysis.The device history record was also 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, however there may have been under comorbidities and inadequate myocardial preservation that led to the need for a lvad.Information from field indicated that the physician thought patient death was unrelated to the valve and that it was possibly due to undiagnosed pulmonary hypertension.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18301293
• Report Number: 2135147-2023-05422
• Device Sequence Number: 15199610
• Product Code: LWQ
• UDI-Device Identifier: 05414734005852
• UDI-Public: 05414734005852
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 02/07/2024

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 Catalogue Number: 19AGFN-756
• Device Lot Number: 8176623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• 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 Age: 46 YR
• Patient Sex: Female