MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, B.V. (CD) SJM MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 23AJ-501

Device Problem Material Separation (1562)

Patient Problem Mitral Insufficiency (1963)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020 a sjm masters series mechanical heart valve was chosen for the procedure.The physician reported during the procedure, the device was implanted and the user noticed the leaflet detached.Additional information has been requested.2/24 pm.

Manufacturer Narrative

Additional information h10, h3 and h6 ; the reported event of the leaflets fractured and dislodged during rotation was confirmed.One leaflet had dislodged and fractured into multiple pieces, part of which was not returned.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.There was no evidence of material defect in the carbon coating that may have caused or contributed to the fractured leaflet.The cause of the reported event could not be conclusively determined, however it is consistent with damage caused by some external force applied to the leaflet and orifice, which overstressed the carbon material.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, B.V. (CD); lot 21; caguas west industrial park; caguas, puerto rico 00726 -099
• MDR Report Key: 9785874
• MDR Text Key: 193266307
• Report Number: 3003681312-2020-00006
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734021111
• UDI-Public: 05414734021111
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 23AJ-501
• Device Catalogue Number: 23AJ-501
• Device Lot Number: 7023832
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention