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

Model Number	25MTJ-503
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Mitral Regurgitation (1964)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016, a 25mm masters heart valve was implanted in the mitral position.On (b)(6) 2018, a re-do mvr was performed due to perivalvular leakage (pvl) caused by mitral annular calcification (mac) between the patient's native annulus and the middle of the posterior wall.The device was explanted and replaced with a 27mm masters heart valve (serial number unknown).The physician attributes the patient's disease to have caused this event, and not related to the valve.
Additional Manufacturer Narrative
An event of paravalvular leakage was reported.Morphological and histopathological examination revealed the leaflets opened and closed full with mild resistance due to the fact that the valve had not been stored in solution, drying out the bodily fluids, following explant.There was no visible material within the recessed pivot areas.No inflammation or significant calcifications were found within the sewing cuff.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Information from the field indicated that the event was "caused by mitral annular calcification between the patient's native annulus and the middle of the posterior wall.".

• Brand Name: SJM MASTERS SERIES HEART VALVE W/TEFLON 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: 7864465
• Report Number: 2648612-2018-00075
• Device Sequence Number: 1567525
• Product Code: LWQ
• UDI-Device Identifier: 05414734053617
• UDI-Public: 05414734053617
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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: 02/10/2020
• Device Model Number: 25MTJ-503
• Device Catalogue Number: 25MTJ-503
• Device Lot Number: 4977910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 11/01/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 46 YR