BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1665656 · Received April 21, 2010

    Report

    Report Number
    2953200-2010-00674
    Event Type
    Death
    Date Received
    April 21, 2010
    Date of Event
    January 7, 2010
    Report Date
    March 22, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVAL RESULTS: ROOT CAUSE UNDETERMINED.

    Description of Event or Problem · 1

    THREE ENDEAVOR RESOLUTE RX DRUG-ELUTING STENTS (2.25 MM X 14MM, 2.50MM X 14MM AND 3.50MM X 15MM) (REF MFR REPORT# 2953200-2010-00675, 2953200-2010-00676) WERE INSERTED INTO A PT FOR TREATMENT OF A LEFT MAIN AND LAD. LESION MORPHOLOGY WAS REPORTED AS SMALL CALCIFIED DIFFUSELY DISEASED CORONARY ARTERIES WITH SIGNIFICANT STENOSIS OF THE LEFT MAIN, PROXIMAL CX AND LAD/ORIGIN DIAGONAL. THE LAD/DIAGONAL WERE DILATED WITH GOBA (BALLOON ONLY). FOLLOWING PRE-DILATATION THE 2.25 MM DIAMETER X 14MM LENGTH STENT WAS IMPLANTED AT THE PROXIMAL CX. STENTS WERE IMPLANTED IN THE LEFT MAIN AND ORIGIN LAD, FOLLOWED BY POST DILATATION TO 4MM. THERE WAS A GOOD ANGIOGRAPHIC RESULT. THE POST OPERATIVE COURSE REPORTED EPISODES OF CHEST PAIN, TROPONIN RISE, HEART FAILURE AND COLLAPSE AFTER SEVEN DAYS. IT IS REPORTED THAT THE PT HAD AN EMERGENCY RE-CATHETERIZATION. THE MAIN ARTERIES WERE OPEN BUT NO FILLING OF THE SMALL SIDE BRANCHES WERE OBSERVED. IT IS REPORTED THAT THE PT DIED A WEEK LATER. AN AUTOPSY WAS PERFORMED WHICH SHOWED EXTENSIVE MYOCARDIAL DAMAGE. FOREIGN MATERIAL WAS NOTED TO BE IN THE COLLATERAL ARTERIES. DEVICES NOT REC'D FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0001066398

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death