BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1103003 · Received August 8, 2008

    Report

    Report Number
    2953200-2008-00669
    Event Type
    Death
    Date Received
    August 8, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 11, 2008
    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

    EVAL RESULTS: OTHER (NO FILMS, OPERATIVE OR AUTOPSY REPORTS PROVIDED). (SUBACUTE THROMBOSIS). CONCLUSION: (NO FILMS, OPERATIVE OR AUTOPSY REPORTS PROVIDED).

    Description of Event or Problem · 1

    A 3.5MM DIAMETER X 18MM LENGTH ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT SYSTEM WAS IMPLANTED INTO A PT FOR THE TREATMENT OF A PROXIMAL CIRCUMFLEX LESION (MDR#2953200-2008-00667). DURING PRE-PROCEDURAL DIAGNOSTIC, TWO LESIONS WERE FOUND IN THE PROXIMAL LAD AND PROXIMAL CIRC. AN ENDEAVOR 3.5 X 18MM WAS PLACED IN THE PROXIMAL CIRC. DURING INFLATION THE STENT MOVED A FEW MM MORE PROXIMAL CLOSER TO THE OSTIUM OF THE LEFT MAIN. AN ENDEAVOR 3.0X 9MM DRUG-ELUTING STENT WAS PLACED IN THE PROXIMAL LAD (MDR#2953200-2008-00668). KISSING BALLOON TECHNIQUE WAS USED TO ASSURE PROPER SIZING. AFTER FURTHER REVIEW IT WAS FOUND THAT THE FIRST ENDEAVOR DRUG-ELUTING STENT (3.5X18MM) DID NOT COVER THE ENTIRE LESION AND A SECOND 3.5 X 9MM ENDEAVOR STENT WAS PLACED DISTAL TO THE FIRST ENDEAVOR DRUG-ELUTING STENT. ALL VESSELS WERE PATENT AND A GOOD ANGIOGRAPHIC RESULT WAS ACHIEVED. IT WAS REPORTED THAT THE PT WAS RELEASED FROM THE HOSPITAL THREE DAYS LATER. THE PT COMPLAINED OF CHEST PAIN LATER THAT NIGHT AND RETURNED TO THE HOSPITAL. A SECOND PROCEDURE SHOWED POSITIVE THROMBUS IN ONE VESSEL. THE PT LATER DIED OF CARDIOGENIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2 NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000610537

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death