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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of improper leaflet function was reported.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.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.
Event or Problem Description
On (b)(6) 2019, a 31mm masters valve was implanted in a (b)(6) male.Following implant, an echo revealed improper leaflet function and the patient was reported to be hemodynamically unstable.The valve was exchanged for another 31mm masters valve (serial number: (b)(4)) and the patient is reported to be stable.

• 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: 8641223
• Report Number: 2648612-2019-00035
• Device Sequence Number: 1831300
• Product Code: LWQ
• UDI-Device Identifier: 05414734006620
• UDI-Public: 05414734006620
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• 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: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2019

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: 02/21/2023
• Device Model Number: 31MJ-501
• Device Catalogue Number: 31MJ-501
• Device Lot Number: 6332997
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR