BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3041943 · Received April 9, 2013

    Report

    Report Number
    9612164-2013-00379
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: FORCE USED, MOST LIKELY FURTHER CONTRIBUTED TO THE STENT DAMAGE. FAILURE TO DELIVER THE STENT AND STENT DEFORMATION. PREVIOUSLY DEPLOYED STENT IN THE LM HAS MOST LIKELY CONTRIBUTED TO THE STENT DAMAGE. DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. CONCLUSION: FAILURE TO DELIVER THE STENT AND STENT DEFORMATION. PREVIOUSLY DEPLOYED STENT IN THE LM HAS MOST LIKELY CONTRIBUTED TO THE STENT DAMAGE. DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. FORCE USED, MOST LIKELY 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 DISTAL LAD WHICH WAS REPORTED TO BE MILDLY TORTUOUS, 80% STENOSED WITH MINIMUM CALCIFICATION. THE LAD HAD BEEN STENTED PREVIOUSLY. NO ABNORMALITY WAS NOTED DURING PREPARATION OR INSPECTION OF THE DEVICE PRIOR TO USE. THE DEVICE WAS UNABLE TO CROSS THE LESION AND UPON REMOVAL IT WAS OBSERVED THAT THE DISTAL STRUT WAS LIFTED. INFORMATION PROVIDED CONFIRMS THAT RESISTANCE WAS NOTED WHEN THE DEVICE WAS ADVANCED TOWARDS THE LESION, ONCE IT HAD EXITED THE TIP OF THE GUIDE CATHETER WITHIN THE PREVIOUSLY STENTED LM. SOME FORCE WAS USED TO DELIVER DEVICE PAST THE PREVIOUSLY STENTED LM TO LESION. THE CASE WAS COMPLETED WITH ANOTHER RESOLUTE STENT. NO CLINICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147559 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006388944

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR