BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3042291 · Received April 9, 2013

    Report

    Report Number
    9612164-2013-00385
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE-FAILURE TO DELIVER STENT AND STENT DEFORMATION; DEFORMATION PROBLEM-STENT SEGMENTS WERE SEVERELY BUNCHED AND DEFORMED; RELATED TO ANOTHER DEVICE-STENT DAMAGE AND INSERTION DIFFICULTIES ARE, MOST LIKELY RELATED TO THE GUIDELINER DEVICE. CONCLUSION: INHERENT RISK OF PROCEDURE-FAILURE TO DELIVER STENT AND STENT DEFORMATION; RELATED TO ANOTHER DEVICE-STENT DAMAGE AND INSERTION DIFFICULTIES ARE, MOST LIKELY RELATED TO THE GUIDELINER DEVICE. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT. THE STENT GOT CAUGHT ON THE GUIDE LINER AND COULD NOT ADVANCE THROUGH. NO ABNORMALITY NOTED DURING PREPARATION OF THE DEVICE PRIOR TO USE. NO CLINICAL SEQUELAE REPORTED. EVALUATION SUMMARY: THE DISTAL STENT SEGMENTS HAD MOVED PROXIMALLY ALONG THE BALLOON. THE DISTAL SEGMENTS WERE SEVERELY BUNCHED AND DEFORMED. THE PROXIMAL PILLOW WAS BUNCHED. CRIMP IMPRESSIONS WERE EVIDENT ON THE EXPOSED DISTAL BALLOON SECTION. THE DISTAL TIP WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145541 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006025423

    Patients

    Seq Age Sex Outcome Treatment
    1