BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY OTW

    MDR report key: 3041971 · Received April 9, 2013

    Report

    Report Number
    9612164-2013-00381
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 6, 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
    CA, 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. CALCIFIED LESION. CONCLUSION: FAILURE TO DELIVER THE STENT AND STENT DEFORMATION. FORCE USED, MOST LIKELY FURTHER CONTRIBUTED TO THE STENT DAMAGE. CALCIFIED LESION. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A RESOLUTE INTEGRITY OVER THE WIRE DRUG ELUTING STENT IN THE RCA WHICH WAS REPORTED TO BE CALCIFIED. NO ABNORMALITY WAS NOTED DURING PREPARATION OF THE DEVICE PRIOR TO USE. RESISTANCE WAS FELT IN THE PROXIMAL RCA WITHIN THE FIRST TURN DOWN. AFTER TRYING FOR A COUPLE OF MINUTES IT WAS FELT THAT IT WAS NOT POSSIBLE TO GET THE RESOLUTE PAST THE FIRST TWO TURNS OF THE VESSEL, DUE TO THE VESSEL CALCIFICATION. POST REMOVAL OF THE STENT IT WAS OBSERVED THE STENT STRUT WAS DAMAGED. THE LESION WAS TREATED WITH STENTING AND BALLOONING. NO CLINICAL SEQUELAE REPORTED. IMAGE REVIEW : TWO STILL PROCEDURAL IMAGES WERE PROVIDED FOR REVIEW. THE FIRST IMAGE SHOWS A DISEASED RCA WITH SIGNIFICANT STENOSIS AND CALCIFICATION PRESENT. THE SECOND IMAGE SHOWS THE RCA WITH STENTS DEPLOYED IN THE PROXIMAL VESSEL. THE IMAGES DO NOT SHOW THE FAILED RESOLUTE INTEGRITY DEVICE INSIDE THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146380 RESOLUTE INTEGRITY OTW STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006114834

    Patients

    Seq Age Sex Outcome Treatment
    1