BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE REVALVING SYSTEM

    MDR report key: 6358951 · Received February 24, 2017

    Report

    Report Number
    2025587-2017-00321
    Event Type
    Injury
    Date Received
    February 24, 2017
    Date of Event
    November 14, 2016
    Report Date
    February 3, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ELEID, M. ET AL. "TRANSCATHETER AORTIC VALVE REPLACEMENT: STATE OF THE ART AND FUTURE DIRECTIONS." ANNU. REV. MED. 2017. 68:15¿28. DOI: 10.1146/ANNUREV-MED-101615-020427. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) TREATMENT HISTORY, CURRENT STATE, AND THE FUTURE DIRECTION. THE ARTICLE IS SUMMARY PULLING FROM MULTIPLE LITERATURE REVIEWS FOCUSED ON TAVR. SEVERAL MANUFACTURERS DEVICES WERE NOTED INCLUDING THE MEDTRONIC EVOLUTR (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: PARAVALVULAR LEAK (PVL), STROKE/CEREBRAL EMBOLIZATION, VASCULAR COMPLICATIONS, CONDUCTION DISTURBANCES (LEFT BUNDLE BRANCH BLOCK, RIGHT BUNDLE BRANCH BLOCK, VARYING DEGREES OF AV BLOCK) WITH PACEMAKER IMPLANT. THE NUMBER OF EVENTS ATTRIBUTED TO THE MEDTRONIC PRODUCT WAS NOT SPECIFIED. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND A MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140049 COREVALVE REVALVING SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R