BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1993818 · Received February 11, 2011

    Report

    Report Number
    2953200-2011-00366
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 9, 2011
    Report Date
    January 12, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - RESULTS: (GI BLEED AND REVASCULARIZATION).

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS WERE IMPLANTED; ONE IN THE PROXIMAL RCA AND ONE IN THE MID RCA. IT IS REPORTED THAT THE PT HAD A COMPLETE HEART BLOCK AT TIME OF INDEX PROCEDURE AND A TEMPORARY PACEMAKER WAS INSERTED. IT IS REPORTED THAT THE PT HAD A PERMANENT PACEMAKER INSERTED APPROX 4 DAYS POST INDEX PROCEDURE. THERE WAS A THIRD ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT IMPLANTED IN THE MID LAD APPROX 6.5 WEEKS POST INDEX PROCEDURE. IT IS REPORTED THAT THE PT WAS ADMITTED WITH CHEST PAIN APPROX 2.5 MONTHS POST INDEX PROCEDURE. CARDIAC BIOMARKERS WERE NEGATIVE. PT WAS RULED OUT FOR MYOCARDIAL INFRACTION (MI) BUT WAS FOUND TO BE IRON DEFICIENT. PT HAD A FULL GASTROINTESTINAL (GI) EVALUATION WHICH WAS NEGATIVE. PT RECEIVED 2 UNITS OF PACKED RED BLOOD CELL TRANSFUSION. IT IS REPORTED THAT THE PT RECOVERED WITH TREATMENT. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO EITHER THE STUDY DEVICE OR THE STUDY PROCEDURE. PT WAS ADMITTED WITH ACUTE DEEP VEIN THROMBOSIS OF LEFT UPPER EXTREMITY RELATED TO RECENT PACEMAKER APPROX 3 MONTHS POST INDEX PROCEDURE. PT WAS SWITCHED FROM EFFIENT TO PLAVIX AND COUMADIN. IT IS REPORTED THAT THE PT RECOVERED WITH TREATMENT. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO EITHER THE STUDY DEVICE OR THE STUDY PROCEDURE. IT IS REPORTED THAT THE PT WAS ADMITTED FOR BLACK TARRY STOOLS APPROX 3.5 MONTHS POST INDEX PROCEDURE. THE PT WAS FOUND TO HAVE A GI BLEED AND RECEIVED 6 UNITS OF PACKED RED BLOOD CELLS AND 4 UNITS OF FRESH FROZEN PLASMA. IT IS REPORTED THAT THE PT RECOVERED WITH TREATMENT. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO EITHER THE STUDY DEVICE OR THE STUDY PROCEDURE. (REF MFR# 2953200-2011-00367 AND 2953200-2011-00368).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention ASPIRIN| PRASUGREL