MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MECHANICAL HEART VALVE (UNKNOWN); HEART-VALVE, MECHANICAL

Device Problem Obstruction of Flow (2423)

Patient Problem Hemolysis (1886)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

15 years ago a 19mm sjm mechanical heart valve was implanted in the aortic position and a 27mm sjm mechanical heart valve was implanted in the mitral position.During follow-up hemolysis was suspected and the patient was admitted into the hospital.On (b)(6) 2020, both valves were explanted and replaced with a 19mm epic supra valve w/flexfit in the aortic position and a 25mm epic stented porcine heart valve w/flexfit system in the mitral position.The physician believes the hemolysis occurred due to the interrupted blood flow caused by leaflet dysfunction on both valves.The patient was reported to be in stable condition.Manufacturer report number: 2648612-2020-00073.

Manufacturer Narrative

Explant was reported due to hemolysis.The investigation found that there was fibrous pannus ingrowth on the inflow surface of the valve, which narrowed the inflow diameter, but did not impinge upon the leaflets.No material was found in the recessed pivot areas and the leaflets opened and closed with ease.No inflammation or significant calcifications were present.The cause of the reported event could not be conclusively determined.

• Brand Name: SJM MECHANICAL HEART VALVE (UNKNOWN)
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 10206591
• MDR Text Key: 196816752
• Report Number: 2648612-2020-00072
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR