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

Model Number 25MJ-501

Device Problem Incomplete Coaptation (2507)

Patient Problems Thrombus (2101); Regurgitation (2259)

Event Date 05/31/2019

Event Type  Injury  

Event 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.

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 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
• 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: 8761703
• MDR Text Key: 150118260
• Report Number: 2648612-2019-00051
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006354
• UDI-Public: 05414734006354
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR