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

Model Number	31MJ-501
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of the valve breaking while it was being put in was reported.The results of the investigation are inconclusive since 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 at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
On an unknown date, a 31mm masters valve was selected for implant in the mitral position.When implanting, the valve broke.Another 31mm masters valve was used to complete the procedure.No additional information was received.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Common Device Name: 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: 9579539
• Report Number: 3003681312-2020-00002
• Device Sequence Number: 2197008
• Product Code: LWQ
• UDI-Device Identifier: 05414734006620
• UDI-Public: 05414734006620
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2022
• Device Model Number: 31MJ-501
• Device Catalogue Number: 31MJ-501
• Device Lot Number: 5982529
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/12/2020
• 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: Other