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

Model Number	25MECJ-502
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	10/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2010, a 25mm carpentier-edwards perimount valve was implanted in the mitral position.On (b)(6) 2019, the non-abbott valve was explanted due to calcification and a 25mm sjm masters series valve expanded cuff was implanted.Two months later, on (b)(6) 2019, a re-do mvr was performed due to thrombosis on the valve.It was replaced with a 23mm magna mitral ease (by edwards lifesciences, serial: unknown).The patient was prescribed (b)(4) and will follow up with regular check-ins.
Event or Problem Description
On (b)(6) 2010, a 25mm carpentier-edwards perimount valve was implanted in the mitral position.On (b)(6) 2019, the non-abbott valve was explanted due to calcification and a 25mm sjm masters series valve expanded cuff was implanted.Two months later, on (b)(6) 2019, a re-do mvr was performed due to thrombosis on the valve.It was replaced with a 23mm magna mitral ease (by edwards lifesciences, serial: unknown).The patient was prescribed warfarin and will follow up with regular check-ins.Details regarding the patient's anticoagulation therapy was unknown.
Additional Manufacturer Narrative
Explant was reported due to thrombus.The investigation found that there was limited mobility of the leaflets.Thrombus was present in both the recessed pivot areas and on the sewing cuff.There were entrapped leukocytes within the thrombus, however no true inflammation 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 thrombus present in the recessed pivot areas would limited the mobility of the leaflets.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• 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: 9307077
• Report Number: 2648612-2019-00094
• Device Sequence Number: 1864775
• Product Code: LWQ
• UDI-Device Identifier: 05414734006347
• UDI-Public: 05414734006347
• 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: 2019
• 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): 12/12/2019

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: 10/23/2022
• Device Model Number: 25MECJ-502
• Device Catalogue Number: 25MECJ-502
• Device Lot Number: 6181309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 12/12/2019
• 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: 54 YR
• Patient Weight: 30