BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTEGRITY RX

    MDR report key: 3091224 · Received May 3, 2013

    Report

    Report Number
    9612164-2013-00502
    Event Type
    Death
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EMBOLISM, DEATH AND MI. DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. CONCLUSION: EMBOLISM, DEATH AND MI. (B)(4).

    Description of Event or Problem · 1

    TWO INTEGRITY BARE METAL STENT WERE IMPLANTED IN THE RCA WITHOUT ANY REPORTED ISSUES. DURING A STAGED PROCEDURE THREE DAYS LATER 2 NON-MEDTRONIC STENTS WERE IMPLANTED IN THE LAD. APPROXIMATELY 3 WEEKS POST THE INDEX PROCEDURE THE PATIENT PRESENTED WITH SYMPTOMS OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM. AS SCREENING WAS BEING CARRIED OUT THE PATIENT SUFFERED A MYOCARDIAL INFARCTION. IT WAS REPORTED THAT THE STENTS WERE OCCLUDED WITH THROMBOSIS AND THE PATIENT EXPIRED. THE PHYSICIAN HAS INDICATED THAT THERE IS A POSSIBILITY THE PATIENT WAS RESISTANT TO DAPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194916 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND INT22526UX

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DAPT