BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY RX

    MDR report key: 3132679 · Received May 29, 2013

    Report

    Report Number
    9612164-2013-00583
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: FAILURE TO FOLLOW INSTRUCTIONS-FORCE USED IN THE ATTEMPT TO DELIVER THE STENT; INHERENT RISK OF PROCEDURE-STENT EMBOLIZATION; LESION MORPHOLOGY-LAD, VERY CALCIFIED. RELATED TO ANOTHER DEVICE-GUIDELINER HAS CONTRIBUTED TO THE STENT DISLODGEMENT; NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED ¿ DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. EVALUATION CONCLUSION: INHERENT RISK OF PROCEDURE-STENT EMBOLIZATION; RELATED TO ANOTHER DEVICE-GUIDELINER HAS CONTRIBUTED TO THE STENT DISLODGEMENT; LESION MORPHOLOGY-LAD, VERY CALCIFIED; FAILURE TO FOLLOW INSTRUCTIONS- FORCE USED IN THE ATTEMPT TO DELIVER THE STENT. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT AN INTEGRITY BARE METAL STENT IN A VERY CALCIFIED LAD WITH THE AID OF A 6 FRENCH GUIDE LINER. NO ABNORMALITIES WERE NOTED DURING DEVICE PREPARATION. THE LESION WAS PRE-DILATED SEVERAL TIMES. FORCE WAS USED TO DELIVER THE STENT TO THE LESION BUT THIS WAS UNSUCCESSFUL AND THE STENT DISLODGED IN THE DISTAL TIP OF THE GUIDE LINER. THE STENT WAS REMOVED WITH A SNARE. THE LESION COULD NOT BE CROSSED WITH ANY STENT. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236603 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND 0006566947

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention