MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 29M-101

Device Problem Incomplete Coaptation (2507)

Patient Problem Corneal Pannus (1447)

Event Date 12/20/2018

Event Type  Injury  

Event Description

29 years ago on (b)(6) 1989, a mitral valve replacement (mvr) was performed and this 29mm mechanical heart valve was implanted in the patient's mitral position.On (b)(6) 2018, despite the patient being asymptomatic, a re-do mvr was performed due to pannus ingrowth which appeared to have extended circumferentially on the valve resulting in immobile leaflets.The valve was explanted and replaced with a 27mm masters series mechanical heart valve (model: 27mj-501, serial unknown).The device was inspected ex vivo and leaflets were observed to be intact.No patient consequences were reported and the patient was discharged.

Manufacturer Narrative

The reported immobile leaflets due to pannus ingrowth was confirmed.Calcified fibrous pannus ingrowth from the outflow surface reached into the interior diameter of the valve and impinged on upon the mechanical leaflets, preventing them from completely opening.No inflammation was found.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications at the time of release to commercialization.The cause of the reported event could not be conclusively determined; however, this valve had been implanted for nearly 30 years.Information from the field also indicated that the valve was replaced with a smaller, 27mm, valve.

• Brand Name: SJM MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 8334166
• MDR Text Key: 135993610
• Report Number: 2648612-2019-00010
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/26/1993
• Device Model Number: 29M-101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 50