BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1202444 · Received October 8, 2008

    Report

    Report Number
    2953200-2008-00899
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    August 22, 2008
    Report Date
    September 8, 2008
    Manufacturer
    MEDTRONIC CARDIOVSCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PENDING CD EVALUATION. DISSECTION. CONCLUSIONS: PENDING CD EVALUATION. SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    A 3.0 MM DIAMETER X 23 MM LENGTH ENDEAVOR RESOLUTE RX DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PATIENT, FOR THE TREATMENT OF A 100% STENOTIC MID LAD LESION. IT WAS REPORTED THAT THE PATIENT SUFFERED AN AMI (ST SEGMENT ELEVATION). A CORONARY ANGIOGRAPHY WAS CARRIED OUT ON THE SAME DAY AT, WHERE AN OCCLUSION OF THE MID LAD WAS OBSERVED. THROMBOSIS ASPIRATION WAS CARRIED OUT WITH A MEDTRONIC EXPORT XT CATHETER. AN ENDEAVOR RESOLUTE DRUG-ELUTING STENT WAS SUCCESSFULLY IMPLANTED AT 16 ATM FOR 30 SECONDS; RESULTS WERE A SMOOTH AND STRAIGHT ARTERY WALL. HOWEVER, A DISSECTION (WITH BLEEDING) OCCURRED AT THE MIDDLE OF THE STENT. A TRANS-THORACIC ECHO-DOPPLER WAS PERFORMED IN THE CATH LAB. NO PERICARDIAL LESION WAS OBSERVED. IN ORDER TO TREAT THE DISSECTION AND TO RESOLVE THE ISSUE, A LONG INFLATION (3 MIN, AT 6 ATM) WAS CARRIED OUT WITH A SPRINTER LEGEND 3.0 X 12MM DILATION BALLOON. RESULT WAS A GOOD OUTCOME, WITH NO PATIENT CONSEQUENCES. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SYNTRON MEDICATION WAS STOPPED TO BE REPLACED BY| HEPARIN A FEW DAYS BEFORE INTERVENTION