BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW

    MDR report key: 1051781 · Received May 21, 2008

    Report

    Report Number
    2953200-2008-00334
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 19, 2008
    Report Date
    April 21, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REQUIRES SECONDARY INTERVENTION.

    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 DISTAL RCA LESION. THE VESSEL WAS NON-CALCIFIED WITH MODERATE TORTUOSITY. THERE WAS A LARGE BEND IN THE VESSEL PROXIMAL TO THE LESION SITE. THE PHYSICIAN WAS USING A HOCKEY STICK GUIDE CATHETER AND ANOTHER MANUFACTURER'S GUIDEWIRE. IT WAS REPORTED THAT AS THE PHYSICIAN WAS AGGRESSIVELY ADVANCING THE STENT DELIVERY SYSTEM, THE GUIDE CATHETER PUSHED ITSELF OUT INTO THE AORTA. THE GUIDE CATHETER LOST POSITION AND THE SDS AND GUIDEWIRE FLEW OUT INTO THE AORTA. THE STENT THEN DISLODGED AND FLOATED TO THE RIGHT SFA WHERE IT REMAINS IN THE PATIENT. THE DISLODGED WILL BE RETRIEVED AT A LATER DATE. THE PHYSICIAN REWIRED AND COMPLETED THE CASE WITH ANOTHER MANUFACTURER'S DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. MEDTRONIC HAS RECEIVED THE DEVICE AND THE FILM ON CD AND THE ANALYSIS IS COMPLETE. THE STENT WAS NOT PRESENT ON THE UN-INFLATED BALLOON. THE STENT WAS NOT RETURNED WITH THE DELIVERY SYSTEM. THE DISTAL AND PROXIMAL PILLOWS WERE DISTRIBUTED AND SLIGHTLY DAMAGED. STENT CRIMP/BAKE IMPRESSIONS WERE EVIDENT ON THE BALLOON. THE CD IMAGES SHOW THE PRESENCE OF A LESION IN THE DISTAL RCA AND A LESION ON THE 2ND BEND IN THE MID DISTAL RCA. THERE ARE NO IMAGES OF THE ENDEAVORS STENTS FAILURE TO CROSS THE LESION OR THE REPORTED GUIDE CATHETER LOOSING POSITION AND THE WIRE FLYING OUT OF THE AORTA. PROCEDURAL IMAGES SHOW THE PRE-DILATATION OF THE DISTAL AND MID TO PROXIMAL LESIONS AND THE SUBSEQUENT STENTING OF THE LESION ON THE 2ND BEND OF THE RCA. PRE-DILATATION OF THE LESION ON THE BEND ON NUMEROUS OCCASIONS INDICATING THAT THE LESION MORPHOLOGY MOST LIKELY IMPACTED ON THE BALLOON'S ABILITY TO FULLY OPEN THE LESION. IT WAS ALSO NECESSARY TO POST DILATE THE STENT THAT WAS DEPLOYED IN THE LESION IN ORDER TO OBTAIN A FULLY PATENT VESSEL. THIS SUGGESTS THAT THE REPORTED RESISTANCE EXPERIENCED BY THE PHYSICIAN DURING ADVANCEMENT OF THE ENDEAVOR OTW DEVICE WAS MOST LIKELY DUE TO THE PATIENT LESION MORPHOLOGY OF THE LESION ON THE 2ND BEND OF THE RCA. THE DISLODGEMENT WAS MOST LIKELY PROCEDURAL RELATED DUE TO THE PATIENT LESION MORPHOLOGY AND DUE TO THE TECHNIQUES BEING USED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000581903

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention