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

Model Number 27MJ-501

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

Patient Problems Hemolysis (1886); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that on 2007, a 27 mm sjm masters series mechanical heart valve was successfully implanted in the mitral position within a patient.On (b)(6) 2021, hemolysis was observed within the patient.The valve was explanted and replaced with a 25 mm non-abbott valve to resolve the event.According to the physician, regurgitation had been observed from some portion of the sewing cuff and the blood flow hit against the hardened area in the auricle of left atrium which might have resulted in the hemolysis.The patient is stable.No additional information was provided.

Manufacturer Narrative

Explant was reported due to hemolysis and "regurgitation had been observed from some portion of the sewing cuff ".The investigation found that the mechanical leaflets opened and closed completely and were freely mobile.There was focal fibrous pannus limited to the sewing cuff.The cause of the reported event could not be conclusively determined.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13175907
• MDR Text Key: 283305390
• Report Number: 2648612-2022-00001
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 55 KG