BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW

    MDR report key: 1013785 · Received March 14, 2008

    Report

    Report Number
    2953200-2008-00135
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    MEDTRONIC CARIDOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    A 3.0 MM DIAMETER X 18 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 MORPHOLOGY WAS REPORTED TO BE SEVERELY TORTUOUS WITH SEVERE CALCIFICATION. IT IS UNKNOWN IF THE LESION WAS PRE-DILATED. IT WAS REPORTED BY THE PHYSICIAN THAT THIS WAS A VERY CHALLENGING CASE. THE PHYSICIAN WAS ATTEMPTING TO DELIVER AN UNKNOWN SIZE ENDEAVOR DRUG-ELUTING STENT DISTALLY, WHEN THE PROXIMAL RCA BECAME DISSECTED. (MFR REPORT# 2953200-2008-00136) THE PHYSICIAN WAS ABOUT TO PERFORM ROTATIONAL ATHERECTOMY, WHEN THE DISSECTION OCCURRED. THE PHYSICIAN IMPLANTED AN ENDEAVOR DRUG-ELUTING STENT TO SEAL THE PROXIMAL DISSECTION. IT WAS REPORTED THAT THE PHYSICIAN WAS THEN ABLE TO DELIVER AN ENDEAVOR DRUG-ELUTING STENT TO THE DISTAL LESION SITE. HOWEVER, WHEN HE TRIED TO REACH THE MID RCA THE STENT BECAME LODGED IN THE PROXIMAL RCA STENT, AND THE STENT DISLODGED. THE PHYSICIAN DEPLOYED THE STENT INTO THE VESSEL WALL AND THE CASE WAS COMPLETED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW NIQ MEDTRONIC CARIDOVASCULAR GALWAY NA 0000606206

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention