BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY RX

    MDR report key: 3121508 · Received May 21, 2013

    Report

    Report Number
    9612164-2013-00550
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: PATIENT¿S CONDITION PREDISPOSED EVENT (TARGET LESION EXHIBITED 100% STENOSIS. RESIDUAL STENOSIS REMAINED FOLLOWING STENT IMPLANT). INHERENT RISK OF PROCEDURE (STENT THROMBOSIS). EVALUATION CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TARGET LESION EXHIBITED 100% STENOSIS. RESIDUAL STENOSIS REMAINED FOLLOWING STENT IMPLANT). KNOWN INHERENT RISK OF PROCEDURE (STENT THROMBOSIS). UNABLE TO CONFIRM COMPLAINT ASSIGNED AS DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED ASSIGNED AS DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PHYSICIAN IMPLANTED AN INTEGRITY BARE METAL STENT TO A CALCIFIED LESION IN THE LAD WITH 100% STENOSIS AND TORTUOSITY. THE INTEGRITY STENT WAS EXPANDED AND APPRESSED ON THE VESSEL WALL IN GOOD CONDITION. HOWEVER, STENOSIS REMAINED DISTAL TO THE STENT WHERE THE INTEGRITY STENT COULD NOT BE ADVANCED TO. APPROXIMATELY 3 DAYS LATER PATIENT HAD A STENT THROMBOSIS WHICH WAS TREATED WITH BALLOONING AND STENTING. THE PHYSICIAN ASSESSED THAT THERE WAS NO RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224632 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND 0006227125

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention