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 Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

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 mechanical heart valve was selected for a procedure.The flap of the heart valve vibrated and the shaft piece fell off and the valve was not used.The procedure was successfully completed by using a different valve.The patient remained stable through out and post procedure.A clinically significant delay was reported, but there was no patient consequences or intervention due to this delay.

Manufacturer Narrative

Correction: manufacturer report 2648612-2020-00092, should not have been reported as a medical device report (mdr).Additional information indicated that there was no clinically significant delay and the event did not lead or cause serious injury or death.As such, the event is not reportable.

Event Description

On aug 12, 2020 a mechanical heart valve was selected for a procedure.The flap of the heart valve vibrated and the shaft piece fell off and the valve was not used.The procedure was successfully completed by using a different valve.The patient remained stable through out and post procedure.A clinically significant delay was reported, but there was no patient consequences or intervention due to this delay.

• 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
• MDR Report Key: 10516488
• MDR Text Key: 211687668
• Report Number: 2648612-2020-00092
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2020
• Device Model Number: 27MJ-501
• Device Lot Number: 5262901
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1