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

Model Number	31MJ-501
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a 31mm masters valve was implanted in the mitral position.Post procedure after closing the chest, the physician observed that one of the leaflets was not moving properly.The chest was reopened and the physician explanted the 31mm masters valve.A 29mm masters valve was successfully implanted.The patient is reported to be stable.
Event or Problem Description
On (b)(6) 2019, a 31mm masters valve was implanted in the mitral position.Post procedure after closing the chest, the physician observed that one of the leaflets was not moving properly.The chest was reopened and the physician explanted the 31mm masters valve.A 29mm masters valve was successfully implanted.The patient is reported to be stable.
Additional Manufacturer Narrative
An event of one of the leaflets not moving properly could not be confirmed.Morphological and hydrodynamic examination indicated the valve met abbott specifications.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.Hydrodynamic testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The cause of the reported event could not be conclusively determined.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• 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: 8561968
• Report Number: 2648612-2019-00032
• Device Sequence Number: 2192011
• Product Code: LWQ
• UDI-Device Identifier: 05414734006620
• UDI-Public: 05414734006620
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

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: 05/09/2019
• Device Model Number: 31MJ-501
• Device Catalogue Number: 31MJ-501
• Device Lot Number: 4605183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 07/09/2019
• 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: Required Intervention
• Patient Age: 53 YR