BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY OTW

    MDR report key: 3192642 · Received June 27, 2013

    Report

    Report Number
    9612164-2013-00673
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE-FAILURE TO DELIVER THE STENT AND STENT DEFORMATION; LESION MORPHOLOGY-CALCIFIED AND TORTUOUS LESION; NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED ¿ DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW; RELATED TO OPERATIONAL CONTEXT-RETRACTION THROUGH THE VESSEL AND GUIDE CATHETER APPEAR TO HAVE FURTHER CONTRIBUTED TO THE STENT DAMAGE. EVALUATION, CONCLUSION: INHERENT RISK OF PROCEDURE-FAILURE TO DELIVER THE STENT AND STENT DEFORMATION; LESION MORPHOLOGY-CALCIFIED AND TORTUOUS LESION; UNABLE TO CONFIRM COMPLAINT-DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW; RELATED TO OPERATIONAL CONTEXT-RETRACTION THROUGH THE VESSEL AND GUIDE CATHETER APPEAR TO HAVE FURTHER CONTRIBUTED TO THE STENT DAMAGE. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A RESOLUTE INTEGRITY DRUG ELUTING STENT IN THE 2ND OM WHICH EXHIBITED SEVERE TORTUOSITY, MODERATE TO SEVERE CALCIUM AND 90-95% STENOSIS. DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. INFORMATION PROVIDED INDICATES THAT THE GUIDE WAS HAVING TROUBLE STAYING SEEDED. THE RESOLUTE WAS UNABLE TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED A RAISED STENT STRUT WAS NOTED. IT WAS REPORTED THAT, AS AN ATTEMPT WAS BEING MADE TO WITHDRAW THE DEVICE THE GUIDE SUCKED INTO THE LEFT MAIN. IT IS POSSIBLE THAT, AS THE STENT PLATFORM WAS REMOVED THE STENT MAY HAVE GOT CAUGHT ON THE TIP OF THE GUIDE AND RESULTED IN A RAISED STRUT. ANOTHER STENT WAS IMPLANTED . NO CLINICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294638 RESOLUTE INTEGRITY OTW STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006432393

    Patients

    Seq Age Sex Outcome Treatment
    1