BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1931117 · Received November 11, 2010

    Report

    Report Number
    2953200-2010-02195
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 12, 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
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD (B)(4) FILM. EVALUATION: RESULTS: (FAILURE TO DELIVER STENT, STENT DEFORMATION). (90% STENOSIS, SEVERE CALCIFICATION). CONCLUSIONS: (90% STENOSIS, SEVERE CALCIFICATION). EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. THE FIRST TWELVE PROXIMAL STENT SEGMENTS WERE DEFORMED AND STRETCHED IN A PROXIMAL DIRECTION EXTENDING BEYOND THE PROXIMAL PILLOW AND MARKER BAND. THE DISTAL TIP WAS DAMAGED. A PROTECTIVE SHEATH COULD NOT BE PLACED OVER THE STENT DUE TO THE DEFORMED STENT SEGMENTS. CD IMAGES AND PROCEDURAL NOTES WERE ALSO PROVIDED FOR REVIEW. THE IMAGES CONFIRM SEVERE STENOSIS AND SEVERE CALCIFICATION OF THE RCA LESION. THE IMAGES ALSO SHOW MULTIPLE PRE-DILATIONS OF THE LESION. THERE WAS NO EVIDENCE OF THE FAILED RESOLUTE ATTEMPT ON THE CD IMAGES; HOWEVER, THE PROCEDURAL NOTES STATE THAT FOLLOWING THE UNSUCCESSFUL ATTEMPT TO DEPLOY THE RESOLUTE, AN "ANCHOR WIRE" WAS USED TO SUPPORT THE NEXT DELIVERY ATTEMPT, AS CAN BE SEEN ON THE CD IMAGES.

    Description of Event or Problem · 1

    AN ENDEAVOR RESOLUTE RX DRUG-ELUTING STENT, LENGTH 30MM, DIAMETER 3.0 MM, WAS INTENDED TO TREAT A LESION IN A PT'S MID - PROXIMAL RCA. IT WAS REPORTED THAT THE STRUTS OF THE RESOLUTE STENT WERE FOUND TO BE DEFORMED WHEN VISUALIZED IN THE OSTIUM OF RCA UNDER CINE. THE TARGET LESION EXHIBITED 90% STENOSIS AND SEVERE CALCIFICATION. THE LESION WAS PRE-DILATED USING MULTIPLE BALLOONS. IT WAS REPORTED THAT RESISTANCE WAS FELT WHILE ADVANCING THE DEVICE TO THE TARGET LESION AND DURING REMOVAL. THE DEFORMED STENT WAS GRADUALLY PULLED BACK IN THE GUIDE CATHETER. ANOTHER RESOLUTE FAILED TO CROSS AN LAD LESION IN THE SAME PROCEDURE (REF MFR REPORT # 2953200-2010-02196). THE PT WAS WELL POST PROCEDURE AND NO CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0003910940

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK