BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 2201857 · Received August 5, 2011

    Report

    Report Number
    9612164-2011-00875
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 7, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS IMPLANTED IN THE MID LAD. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 30 DAY AND 6 MONTH FOLLOW UPS. IT IS REPORTED THAT APPROX 6.5 MONTHS POST INDEX PROCEDURE, THE PT SUFFERED A SPONTANEOUS GASTROINTESTINAL (GI) BLEED. A PRBC TRANSFUSION OF 4 UNITS WAS REQUIRED. INVESTIGATOR HAS INDICATED THAT EVENT WAS NOT RELATED TO STUDY STENT OR PROCEDURES. PT WAS TAKING ASPIRIN & CLOPIDOGREL 24 HOURS PRIOR TO THE EVENT. A PCI REVASCULARIZATION WAS CARRIED OUT APPROX 9.5 MONTHS POST INDEX PROCEDURE. TWO INTEGRITY RAPID EXCHANGE (RX) BARE METAL STENTS WERE IMPLANTED IN THE MED LAD TO TREAT IN-STENT RESTENOSIS. IT IS REPORTED THAT THE PT SUFFERED A NON-STEMI APPROX 12.5 MONTHS POST INDEX PROCEDURE. IT IS REPORTED THAT THE PT WAS TRANSFERRED TO ANOTHER HOSP AS A CABG WAS REQUIRED. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 1.5 YEAR F/U. (REF MFR #9612164-2011-00874, 00875, 00876).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR CLOPIDOGREL| ASPIRIN