BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC SUPRA STENTED TISSUE VALVE

    MDR report key: 8966168 · Received September 5, 2019

    Report

    Report Number
    3001883144-2019-00078
    Event Type
    Injury
    Date Received
    September 5, 2019
    Date of Event
    July 15, 2019
    Report Date
    November 19, 2019
    Manufacturer
    ST. JUDE MEDICAL CATD
    Product Code
    LWR
    PMA / PMN Number
    P040021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT REPORTEDLY PRESENTED WITH SHORTNESS OF BREATH AND WEAKNESS, WITH HIGH GRADIENT DUE TO STRUCTURAL VALVE DETERIORATION. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    CORRECTION: PLEASE RETRACT THIS REPORT 3001883144-2019-00078, THE SAME ISSUE WAS PREVIOUSLY REPORTED AS 3008452825-2019-00408.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A 21MM EPIC VALVE WAS IMPLANTED. ON 15 (B)(6) 2019, THE PATIENT PRESENTED TO HOSPITAL WITH SYMPTOMS OF SHORTNESS OF BREATH AND WEAKNESS. AN ECHO WAS DONE AND REVEALED THAT THE PATIENT WAS HAVING A HIGH GRADIENT DUE TO STRUCTURAL VALVE DETERIORATION. THE DEVICE REMAINS IMPLANTED AND IS PENDING REDO OPERATIONS.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A 21MM EPIC VALVE WAS IMPLANTED. ON (B)(6) 2019, THE PATIENT PRESENTED TO HOSPITAL WITH SYMPTOMS OF SHORTNESS OF BREATH AND WEAKNESS. AN ECHO WAS DONE AND REVEALED THAT THE PATIENT WAS HAVING A HIGH GRADIENT DUE TO STRUCTURAL VALVE DETERIORATION. THEN, THE PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT (AVR) WITH AN UNKNOWN SIZED UNKNOWN DEVICE. THE PATIENT IS STABLE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE AVR. ADDITIONAL INFORMATION RECEIVED ON 11 SEPTEMBER 2019 DETERMINED THIS EVENT IS A DUPLICATE OF PER-2019-0151778.

    Additional Manufacturer Narrative · 1

    THE VALVE WAS REPORTEDLY EXPLANTED, AS THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND WEAKNESS, WITH HIGH GRADIENT DUE TO STRUCTURAL VALVE DETERIORATION. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, A 21MM EPIC VALVE WAS IMPLANTED. ON (B)(6) 2019, THE PATIENT PRESENTED TO HOSPITAL WITH SYMPTOMS OF SHORTNESS OF BREATH AND WEAKNESS. AN ECHO WAS DONE AND REVEALED THAT THE PATIENT WAS HAVING A HIGH GRADIENT DUE TO STRUCTURAL VALVE DETERIORATION. THEN, THE PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT (AVR) WITH AN UNKNOWN SIZED UNKNOWN DEVICE. THE PATIENT IS STABLE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE AVR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759846 EPIC SUPRA STENTED TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL CATD E100-21A 6336918

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R