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

Device Problem Obstruction of Flow (2423)

Patient Problems Calcium Deposits/Calcification (1758); Mitral Regurgitation (1964)

Event Date 08/20/2018

Event Type  Injury  

Event 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.

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
• 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: 7864465
• MDR Text Key: 119824555
• Report Number: 2648612-2018-00075
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734053617
• UDI-Public: 05414734053617
• 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: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR