BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3922133 · Received July 9, 2014

    Report

    Report Number
    9612164-2014-00755
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    September 8, 2010
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS, CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (DISSECTION). (B)(4).

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT DRUG ELUTING STENT WAS IMPLANTED IN THE RCA DURING THE INDEX PROCEDURE. 12 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT A STAGED PROCEDURE 5 STENTS WERE USED - ONE ENDEAVOR SPRINT DRUG ELUTING STENT WAS IMPLANTED IN THE CX, TWO ENDEAVOR SPRINT DRUG ELUTING STENTS WERE IMPLANTED IN THE LAD. A DISSECTION OCCURRED DURING LAD STENT IMPLANTATION. A FURTHER TWO ENDEAVOR SPRINT DRUG ELUTING STENTS WERE IMPLANTED IN THE 1ST DIAGONAL. STENT RECOIL WAS REPORTED TO HAVE OCCURRED DURING 1ST DIAGONAL STENT IMPLANTATION AND AN ADDITIONAL STENT WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401200 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0000876282

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention