BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW

    MDR report key: 1120003 · Received August 14, 2008

    Report

    Report Number
    2953200-2008-00694
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 16, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.5 MM DIAMETER X 15 MM LENGTH ENDEAVOR OTW DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF A MID RCA LESION WITH 100% PRE-STENOSIS AND 10MM IN LENGTH. IT WAS REPORTED THAT MID AND PROXIMAL RCA LESIONS WERE TARGETED. BOTH LESIONS WERE PRE-DILATED. A 4.0 X 12 MM STENT BY ANOTHER MANUFACTURER WAS DEPLOYED AT THE PROXIMAL RCA LESION. THE MID RCA LESION WAS PRE-DILATED USING MULTIPLE MAVERICK BALLOONS AND A 3.5 X 12 MM STENT BY ANOTHER MANUFACTURER WAS ATTEMPTED TWICE BUT COULD NOT CROSS THE MID RCA LESION. THE PHYSICIAN THEN INSERTED A 3.5 X 15 MM ENDEAVOR OTW DRUG-ELUTING STENT BUT COULD NOT CROSS THE LESION. IT WAS REPORTED WHEN THE PHYSICIAN REMOVED EVERYTHING, THE ENDEAVOR DRUG-ELUTING STENT WAS NOTICED NOT ON THE BALLOON. THE STENT WAS LOCATED IN THE TOUHY. THE PATIENT WAS REPORTED TO BE FINE. MEDTRONIC HAS RECEIVED THE DEVICE AND ITS ANALYSIS HAS BEEN COMPLETED. THE DISTAL TIP WAS DAMAGED. THERE WAS A KINK AT 9.7 CM PROXIMAL TO THE DISTAL TIP AND 27.5CM DISTAL TO THE STRAIN RELIEF. SOLUTION WAS EVIDENT WITHIN THE INNER TUBING. THE BALLOON HAD NOT BEEN INFLATED. THE BALLOON PILLOWS WERE INTACT AND CRIMP BAKE IMPRESSIONS WERE EVIDENT ON THE BALLOON. BLOOD RESIDUE WAS EVIDENT BETWEEN THE BALLOON FOLDS. INFORMATION PROVIDED FROM THE ACCOUNT CONFIRMED THAT THREE PRE-DILATIONS WERE PERFORMED ON THE LESION. THE PRE-DILATATIONS MAY NOT HAVE BEEN SUFFICIENTLY EFFECTIVE IN OPENING THE STENOSIS AND THIS MAY HAVE RESULTED IN THE RESISTANCE EXPERIENCE DURING DELIVERY OF THE ENDEAVOR DRUG-ELUTING STENT. INFORMATION PROVIDE ALSO CONFIRMED THAT THE ENDEAVOR STENT HAD PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN WITHDRAWING THE STENT BACK THROUGH THE GUIDE CATHETER AND THE STENT WAS LOCATED IN THE TOUHY. THE POSSIBILITY EXISTS THAT THE STENT SECUREMENT MAY HAVE BEEN IMPACTED BY ATTEMPTS TO ADVANCE THE STENT ACROSS THE LESION AND THIS IN TURN RESULTED IN THE RESISTANCE FELT AS THE STENT WAS WITHDRAWN THROUGH THE GUIDE CATHETER AND THE SUBSEQUENT DISLODGEMENT. COMMUNICATIONS FROM THE FIELD CONFIRMED THAT THE STENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000648727

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK