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

Model Number	21MECJ-502
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Further information regarding this event has been requested.
Event or Problem Description
On (b)(6) 2020, a 21mm sjm masters series valve expanded cuff was selected for implant.During implant, one of the leaflets "popped of." the missing leaflet was attempted to be located by using fluro however, it could not be located.The patient ended up expiring.Additional information has been requested and is pending.
Event or Problem Description
On (b)(6) 2020, a 21mm sjm masters series valve expanded cuff was selected for implant.During implant, one of the leaflets "popped of." the missing leaflet was attempted to be located by using fluro however, it could not be located.The patient ended up expiring on (b)(6) 2020.The cause of death includes congestive heart failure, prosthetic valve failure, mitral valve and rheumatic heart disease.
Additional Manufacturer Narrative
Additional information: b2, b5, h6.
Additional Manufacturer Narrative
An event of leaflet dislodgement and subsequent patient death was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• Common Device Name: 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: 11243981
• Report Number: 2648612-2021-00009
• Device Sequence Number: 19815317
• Product Code: LWQ
• UDI-Device Identifier: 05414734006057
• UDI-Public: 05414734006057
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2022
• Device Model Number: 21MECJ-502
• Device Catalogue Number: 21MECJ-502
• Device Lot Number: 5913006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/02/2021; 04/29/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 03/04/2021; 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 61 YR