MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES HEART VALVE W/TEFLON CUFF; HEART-VALVE, MECHANICAL

Model Number 25MTJ-503

Device Problems Backflow (1064); Perivalvular Leak (1457); Biocompatibility (2886)

Patient Problems Aortic Regurgitation (1716); Thrombus (2101); Hemolytic Anemia (2279)

Event Date 10/03/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2006, an mvr was performed and a 25mm sjm masters series heart valve w/teflon cuff was implanted in the patient's mitral position in another hospital ((b)(6) heart center).Hemolytic anemia, paravalvular leakage (pvl), and aortic regurgitation(trivial) were confirmed in a follow-up, and a re-do mvr was performed on (b)(6) 2020.The sjm masters valve was explanted, replaced with a 23mm sjm masters series heart valve w/teflon cuff.The issue was thought to be due to hemolysis caused by the pvl, but thrombus was also confirmed near the pivot guard of the valve upon explant, and so analysis on the valve was requested.

Manufacturer Narrative

The valve was reportedly explanted for paravalvular leakage and homlytic anemia.The thrombus noted upon explant was confirmed.The leaflets opened and closed completely and easily upon return to abbott.A small piece of thrombus was present within one recessed pivot area.Trace thrombus was also noted within the sewing cuff.No inflammations or calcifications were present.While hemolysis is a known potential adverse event, the cause of the paravalvular leakage and subsequent hemolysis in the reported event could not be conclusively determined.

• Brand Name: SJM MASTERS SERIES HEART VALVE W/TEFLON CUFF
• 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: 10759147
• MDR Text Key: 213870189
• Report Number: 2648612-2020-00109
• 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: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25MTJ-503
• Device Catalogue Number: 25MTJ-503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 55