BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 2080563 · Received April 22, 2011

    Report

    Report Number
    9612164-2011-00275
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    October 12, 2009
    Report Date
    March 26, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (SECONDARY INTERVENTION- REVASCULARIZATION). RESULT: (REVASCULARIZATION).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, TWO STENTS WERE IMPLANTED; A DRIVER RX STENT DIAMETER 4MM LENGTH 18MM WAS IMPLANTED IN THE RCA AND A NON-MEDTRONIC STENT WAS IMPLANTED IN THE LCX. PT HAD STABLE ANGINA AT 30 DAY F/U AND WAS ASYMPTOMATIC AT 6 MONTH AND 1 YR FOLLOW UPS. PT WAS FOUND TO HAVE STABLE ANGINA AT 1.5 YR F/U AND SUBSEQUENTLY UNDERWENT PTCA REVASCULARIZATION WITH IMPLANT OF A DRIVER SPRINT STENT IN THE MID RCA. THE INVESTIGATOR REPORTS THAT THE EVENT HAD NO RELATION TO THE STUDY DEVICE/PROCEDURE AND WAS NOT LIFE THREATENING. PT HAD STABLE ANGINA AT 2 F/U AND WAS ASYMPTOMATIC AT 2.5 YR F/U.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER RX CORONARY STENT SYSTEM MAF MEDTRONIC IRELAND NA 0000674497

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R