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

Catalog Number UNK REGENT HEART VALVE

Device Problems Patient-Device Incompatibility (2682); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Literature article: a case of prosthetic aortic valve dysfunction cause of pannus formation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article, ¿case report; prosthetic valve dysfunction in aortic position due to pannus formation¿, was reviewed.The article presents a case study of an 80-year-old male patient with a history of severe aortic stenosis who had previously undergone an aortic valve replacement procedure on an unknown date 15 years ago.It was reported on an unknown date, a 21mm sjm regent aortic valve was implanted.It was reported 2 months later, the patient presented with respiratory discomfort and the patient was referred to another hospital.On a later unknown date, a transthoracic echocardiography (tte) confirmed severe aortic stenosis and moderate regurgitation.It was also confirmed via fluoroscopy that one leaflet was immobilized and another leaflet was observed to have limited mobility.A decision was made to explant the device on an unknown date.During the procedure, it was observed pannus had formed and covered the leaflet hinge.Thrombus was not reported.An unknown replacement valve was implanted.[the primary author was tatsuya tochigi, clinical laboratory division, matsue red cross hospital, 200 horomachi, matsue, shimane 690-8506, japan].

Manufacturer Narrative

As reported in a research article prosthetic valve dysfunction in aortic position due to pannus formation.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 17455063
• MDR Text Key: 320572356
• Report Number: 2135147-2023-03400
• 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,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: No
• 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: 08/09/2023
• 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 Age: 80 YR
• Patient Sex: Male