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

Model Number 25AGFN-756

Device Problem Perivalvular Leak (1457)

Patient Problems Angina (1710); Arrhythmia (1721); Dyspnea (1816)

Event Date 05/30/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2021 a 25mm regent aortic mechanical heart valve (mhv) was chosen for implant.The patient had developed symptoms of chest tightness, palpitations, shortness of breath and chest pain.Sometime in (b)(6) of 2022, a perivalvular leak (4mm) was discovered.On (b)(6) 2022 the valve was explanted and bicuspid aortic valve malformation was reported.The patient's aortic valve has only two lobes, the open valve orifice area had decreased, the blood flow from the left ventricle to the aorta was blocked.A new, 23mm regent aortic mhv was successfully implanted.The patient remained stable throughout the procedure.The patient was reported to have been stable.

Manufacturer Narrative

An event of paravalular leakage one year after implant, so the valve was replaced was reported.Abbott requested images of the explanted valve, echo imaging showing the leak, and the circumstances leading to explant which were not able to be provided.A returned device assessment, to see if there was any anomalies with the valve 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 available information, the root cause of the reported event of paravalular leak could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Type of Device: 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: 14846562
• MDR Text Key: 295113460
• Report Number: 2135147-2022-00449
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006262
• UDI-Public: 05414734006262
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25AGFN-756
• Device Catalogue Number: 25AGFN-756
• Device Lot Number: 7738763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Weight: 63 KG