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

Model Number	25MJ-501
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Thrombus (2101); Regurgitation (2259)
Date of Event	05/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016, a 25mm masters valve was implanted.The patient was diagnosed with breast cancer and required radiation and surgery.Due to surgical operations, the patients anticoagulation therapy was stopped and started several times resulting in thrombus formation.On (b)(6) 2019, the device was explanted due to leakage.During explant, thrombus was observed on the pivot guard.The physician attempted to clean the valve, but the leaflets didn't function correctly so the physician decided to replace the valve with an edwards tissue valve.The patient is reported to be stable.The patient reported issues of dyspnea since the implant date.
Additional Manufacturer Narrative
The reported event of thrombus, the leaflets not functioning correctly, and leakage could not be confirmed.Both leaflets opened and closed completely and without resistance.On the sewing cuff there was fibrous pannus with scattered calcifications.No acute 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 at the time of commercialization.The cause of the reported event could not be conclusively determined; however, per the site "the patients anticoagulation therapy was stopped and started several times resulting in thrombus formation".
Event or Problem Description
On (b)(6) 2016, a 25mm masters valve was implanted.The patient was diagnosed with breast cancer and required radiation and surgery.Due to surgical operations, the patients anticoagulation therapy was stopped and started several times resulting in thrombus formation.The patient reported issues of dyspnea.On (b)(6) 2019, the device was explanted due to leakage.During explant, thrombus was observed on the pivot guard.The physician attempted to clean the valve, but the leaflets didn't function correctly so the physician decided to replace the valve with an edwards tissue valve.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: 8761703
• Report Number: 2648612-2019-00051
• Device Sequence Number: 2637544
• Product Code: LWQ
• UDI-Device Identifier: 05414734006354
• UDI-Public: 05414734006354
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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: 09/08/2021
• Device Model Number: 25MJ-501
• Device Catalogue Number: 25MJ-501
• Device Lot Number: 5637957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 07/04/2019
• Supplement Report FDA Received Date: 08/16/2019
• 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: 46 YR