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

Model Number	25MECJ-502
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2648612-2019-00023
• Device Sequence Number: 1723995
• Product Code: LWQ
• UDI-Device Identifier: 05414734006347
• UDI-Public: 05414734006347
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 06/25/2019
• 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: 32 YR