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

Model Number	27MJ-501
Medical Device Problem Codes	Obstruction of Flow (2423); Biocompatibility (2886)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Pneumonia (2011); Low Cardiac Output (2501); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	06/03/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2021 a patient underwent an explant of their 27 mm, sjm masters series mechanical heart valve on (b)(6) , 2021.The reason for the explant is unknown and the device (s/n (b)(4)) has been discarded and will not be returned for analysis.Three months later, on (b)(6) 2021, the patient required another re-do mitral valve replacement (mvr) and the second 27 mm, sjm masters series mechanical heart valve (s/n (b)(4)) was explanted.The need for explant three months post implant remains unknown, however.The patients pre-explant international normalized ratio (inr) was 3.4 units.Thrombus was found inside the leaflet hinge which appeared to be impeding the leaflets ability to open and close, causing the leaflets to stick.The patients condition may have also played a role.The second sjm masters series mechanical heart valve, (s/n (b)(4)) will be returning for analysis.A full multifaceted investigation has been requested from the implanting physician.No further information has been provided.Related manufacturer reference #3007113487-2021-00010.
Event or Problem Description
It was reported that on (b)(6) 2018 a 27mm sjm masters series mechanical heart valve (s/n (b)(6)) was implanted.On (b)(6) 2021 the patient underwent an explant of the 27 mm, sjm masters series mechanical heart valve.The reason for the explant is unknown.Upon explant of the valve, pannus had been observed.A replacement 27mm sjm masters series mechanical heart valve (s/n (b)(6)) was implanted.Three months later, on (b)(6) 2021, the patient required re-do mitral valve replacement (mvr) and the 27 mm, sjm masters series mechanical heart valve (s/n (b)(6)) was explanted.The need for explant three months post implant remains unknown.The patients pre-explant international normalized ratio (inr) was 3.4 units.Thrombus was found inside the leaflet hinge which appeared to be impeding the leaflets ability to open and close, causing the leaflets to stick.The patient's condition may have also played a role, however, the physician confirms the patient did not have a history of coagulation issues such as protein deficiencies, cancer or smoking etc.An epic stented porcine heart valve was implanted during the procedure and was noted to have been functioning properly.Subsequent to the initially filed information, the following information was received on 15 july, 2021.Two weeks post re-do mvr, the patient's condition had not improved.It was reported the patients flows were 1.9l and the patient's ejection fraction (ef) to be 20%.The patient was diagnosed with pneumonia.31 days post operatively, the patient was reported to have passed away on (b)(6) 2021.In the physicians opinion, the patient's death was related to the cardiac arrest during the procedure on (b)(6) 2021 and the patients inability to improve post implant.The need for a re-do mvr three months after the last operation is also reported as a contributing cause to the patient's death.No additional information provided.Related manufacturer reference #3007113487-2021-00010.
Additional Manufacturer Narrative
Explant was reported due to thrombus and malfunction of leaflets.The investigation found that the mechanical leaflets were immobilized in the closed position.There was organizing thrombus with focal calcifications at both pivot recesses.There was incomplete closure of mechanical leaflets.No inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The immobilizing thrombus would have contributed to the leaflets malfunction.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12118349
• Report Number: 2648612-2021-00068
• Device Sequence Number: 16984649
• Product Code: LWQ
• UDI-Device Identifier: 05414734006460
• UDI-Public: 05414734006460
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/20/2024
• Device Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Device Lot Number: 7285420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 07/15/2021; 11/04/2021
• Initial Report FDA Received Date: 07/05/2021
• Supplement Report FDA Received Date: 08/13/2021; 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 55 YR
• Patient Sex: Male