MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL

Model Number 25MECJ-502

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombus (2101)

Event Date 03/13/2019

Event Type  Injury  

Event Description

On (b)(6) 2016, a 25mm masters valve was implanted in the mitral position.On (b)(6) 2019, the device was explanted.Upon explant it was observed one leaflet was obstructed and not functioning as expected and thrombus was observed.The patient was reported to have been compliant with their anticoagulation medication.Subsequently another 25mm valve was implanted.The patient is reported to be stable postoperatively.

Manufacturer Narrative

The reported event of "one leaflet was obstructed and not functioning as expected" and thrombus could not be confirmed.Both leaflets opened and closed completely and without resistance.There was fibrous pannus ingrowth limited to the sewing cuff.No inflammations or significant calcifications were 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 leaflet obstruction and thrombus could not be conclusively determined.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 8492856
• MDR Text Key: 141242259
• Report Number: 2648612-2019-00023
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006347
• UDI-Public: 05414734006347
• 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: 06/25/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2021
• Device Model Number: 25MECJ-502
• Device Lot Number: 5503793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 05/31/2019
• Supplement Dates FDA Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR