BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1832356 · Received September 3, 2010

    Report

    Report Number
    2953200-2010-01686
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 6, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS: OTHER (ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED BASED ON LIMITED DETAILS PROVIDED), (STENT FRACTURE).

    Description of Event or Problem · 1

    A 2.75 MM DIAMETER X 30MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR TREATMENT OF A LESION IN A STENT VEIN GRAFT (SVG) TO THE OM (OBTUSE MARGINAL) BY TRANS-RADIAL APPROACH. A 2.5 X 14 DRIVER STENT DISTAL STENT WAS INITIALLY DEPLOYED. DIFFICULTY WAS THEN EXPERIENCED IN CROSSING THIS PREVIOUSLY DEPLOYED STENT. THE 2.75 X 30 ENDEAVOR RESOLUTE STENT WAS DEPLOYED ON THE PROXIMAL END WITH 1 MM OVER-LAPPING INTO DRIVER STENT AT 9 ATM. AFTER THE DEPLOYMENT OF THE ENDEAVOR RESOLUTE STENT A PARTIALLY UN-DEPLOYED AREA OF THE ENDEAVOR STENT WAS POST-DILATED WITH A 2.75 X 10 NON-COMPLIANT BALLOON. SUBSEQUENT TO THIS, STRUT FRACTURE AT JUNCTION OF DISTAL AND MID THIRD OF ENDEAVOR RESOLUTE WAS OBSERVED. THE STENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED AND THE STENT REACHED THE TARGET LESION WITH NO RESISTANCE EXPERIENCED. PT REPORTED TO BE FINE AND NO ADD'L CLINICAL SEQUELAE WERE REPORTED. PLEASE NOTE THAT THIS DEVICE ERES27530X IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT EN27530X.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0002024627

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK