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	Thrombus (2101)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 31mm masters valve was implanted in the mitral position.During device prep, the leaflets of the valve were able to move; however, following implantation "plant", the physician observed movement of the leaflets with a leaflet tester.Echocardiogram after procedure revealed a blocked leaflet.The valve was repositioned, but obstruction was still observed.The valve was explanted and replaced with a second 31mm masters valve.The explanted valve's leaflets were tested again and were seen moving, but one of the leaflets had less mobility.Post-procedure, insufficiency of the right ventricle was observed so the patient was put on extracorporeal membrane oxygenation (ecmo).On (b)(6) 2018, the second 31mm masters valve was observed with blocked leaflets.The second 31mm masters valve was explanted and a hancook tissue valve (unknown size) was implanted.Thrombus was noted on the second 31mm masters valve.Per report, the user believes the first valve was due to product performance while the second valve's obstruction was due to thrombus from the effects of ecmo.
Additional Manufacturer Narrative
The reported event of ¿one leaflet had less mobility¿ could not be confirmed.Hydrodynamic testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.
Event or Problem Description
On (b)(6) 2018, a 31mm masters valve was implanted in the mitral position in a patient with normal right ventricular function.During device prep, the leaflets of the valve were tested and observed with good mobility.The implant site was debrided and after suturing, the physician observed movement of the leaflets with a leaflet tester.While the chest was open, echocardiogram revealed a blocked leaflet.The valve was repositioned with a valve holder, but obstruction was still observed.The valve was explanted and replaced with a second 31mm masters valve.The explanted valve's leaflets were tested again and were seen moving, but one of the leaflets had less mobility.Post-procedure, insufficiency of the right ventricle was observed and the patient was put on extracorporeal membrane oxygenation (ecmo).On (b)(6) 2018 (five days post-op), the second 31mm masters valve was observed with blocked leaflets, and it was explanted and a medtronic hancock tissue valve (unknown size) was implanted.Thrombus was noted on the second 31mm masters valve and per report, the user believes the first valve was due to the valve performance and the second valve's obstruction was due to thrombus from the effects of ecmo.

• 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: 8050777
• Report Number: 2648612-2018-00093
• Device Sequence Number: 16596080
• Product Code: LWQ
• UDI-Device Identifier: 05414734006620
• UDI-Public: 05414734006620
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2018

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: 04/30/2023
• Device Model Number: 31MJ-501
• Device Catalogue Number: 31MJ-501
• Device Lot Number: 6434676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 12/02/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR