BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTICO TAVI VALVE, 27MM

    MDR report key: 13004099 · Received December 14, 2021

    Report

    Report Number
    3014918977-2021-00108
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    November 23, 2021
    Report Date
    March 7, 2022
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    NPT
    UDI-DI
    05415067012494
    PMA / PMN Number
    G120263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF VALVE MIGRATION WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND 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. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2021, A 27MM PORTICO VALVE WAS SELECTED FOR IMPLANT. AFTER THE VALVE WAS RELEASED FROM THE DELIVERY SYSTEM, THE VALVE "JUMPED" AND MIGRATED INTO THE ASCENDING AORTA, "WELL ABOVE THE CORONARY ARTERIES." THE USER ALLEGED THAT THE CAUSE OF THE MIGRATION WAS "PROBABLY THERE WAS TOO MUCH PRESSURE ON THE VALVE BODY IN THE AREA OF LVOT AND AO ANNULUS AND THIS MADE PHV TO BE SQUEEZED IN THE WIDER AORTA." A SECOND 27MM PORTICO VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED HOME IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896358 PORTICO TAVI VALVE, 27MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ST. JUDE MEDICAL, COSTA RICA LTDA PRT-27 8021378 05415067012494

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention| H