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

Model Number 31MJ-501

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombus (2101)

Event Date 10/10/2018

Event Type  Injury  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 126522561
• Report Number: 2648612-2018-00093
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006620
• UDI-Public: 05414734006620
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR