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

Catalog Number UNK REGENT HEART VALVE

Device Problem Perivalvular Leak (1457)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Renal Failure (2041); Cognitive Changes (2551)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Summarized patient outcomes/complications of mhv-regent were reported in a research article in a subject population with multiple co-morbidities including hypertension, diabetes, malignancy, peripheral vascular disease, cerebral vascular disease, coronary artery disease, atrial fibrillation/flutter, aortic valve stenosis, and aortic valve regurgitation.Some of the complications reported were surgical intervention, cerebrovascular event (stroke), delirium, atrial fibrillation, renal replacement therapy, and paravalvular leak ; these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article, "impact of the barthel index score and prognosis on patients undergoing transcatheter aortic valve replacement and surgical aortic valve replacement", was reviewed.The article presented a retrospective, single center study to examine the relationship between the barthel index (bi) score and postoperative outcomes in patients who underwent transcatheter aortic valve replacement (tavr) and surgical aortic valve replacement (savr).Devices included in this study were sapien xt/3, corevalve evolut r/pro/pro+, cep magna/magna ease, inspiris resilia, trifecta, mitroflow, and sjm regent.The article concluded the bi score at discharge was a significant risk factor for long-term mortality in the savr group, with a cut-off value of 60.0.[the primary and corresponding author was yasumi maze, department of thoracic and cardiovascular surgery, ise red cross hospital, 1-471-2 funae, ise 516-8512, japan, with corresponding email: ymze.19651229@gmail.Com].

• Brand Name: REGENT HEART VALVE
• 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: 18172076
• MDR Text Key: 328553968
• Report Number: 2135147-2023-05088
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK REGENT HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Life Threatening; Disability