BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1844658 · Received September 23, 2010

    Report

    Report Number
    2953200-2010-01807
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 24, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (DEVICE CAUGHT ON PREVIOUSLY DEPLOYED STENT), (USE OF FORCE WHEN WITHDRAWING DEVICE), (STENT EMBOLISM). CONCLUSIONS: (USE OF FORCE WHEN WITHDRAWING DEVICE).

    Description of Event or Problem · 1

    SOURCE LITERATURE REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.5MM DIAMETER X 18MM LENGTH ENDEAVOR RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO A LESION IN THE LAD. THE TARGET LESION WAS REPORTED TO HAVE EXHIBITED 90% STENOSIS. THE PROXIMAL LESION SITE HAD BEEN PREVIOUSLY STENTED WITH MULTIPLE OTHER BRAND STENTS. DURING THE ATTEMPTED DELIVERY OF THE ENDEAVOR STENT, IT BECAME CAUGHT IN THE PROXIMAL STENT SITE. WHEN AN ATTEMPT WAS MADE TO FORCEFULLY REMOVE THE ENDEAVOR STENT, IT DISLODGED OFF THE BALLOON AND BECAME STUCK ON THE LMT TO PROXIMAL LAD. PERCUTANEOUS INTERVENTION WAS REQUIRED TO BE PERFORMED ON THE SAME DAY. A 3.5MM DIAMETER X 24MM LENGTH ENDEAVOR RX DRUG-ELUTING STENT WAS USED TO COVER THE BROKEN STENT. THE DISLODGED STENT WAS SUCCESSFULLY BAILED OUT AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention