BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 2000731 · Received February 16, 2011

    Report

    Report Number
    2953200-2011-00401
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: (60-70% STENOSIS, BIFURCATION). (STENTING OF LESION IN MAIN BRANCH WITHOUT PROTECTION OF LESION IN THE SIDE BRANCH). (OCCLUSION). CONCLUSION: (60-70% STENOSIS, BIFURCATION). (STENTING OF LESION IN MAIN BRANCH WITHOUT PROTECTION OF LESION IN THE SIDE BRANCH).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO DEPLOY A 3.0MM DIAMETER X 15MM LENGTH INTEGRITY RAPID EXCHANGE (RX) CORONARY STENT INTO A PT TO TREAT THE LCX BIFURCATION MAIN BRANCH; HOWEVER, IT WAS REPORTED THAT DURING POST STENTING, THE SIDE BRANCH WAS LOST. THE LCX MAIN BRANCH WAS PRE-DILATED TWICE BEFORE THE USE OF THE 3.0MM DIAMETER X 15MM LENGTH INTEGRITY RAPID EXCHANGE (RX) CORONARY STENT, AND WAS POST-DILATED AFTER THE STENTING PROCEDURE. THE DOCTOR USED NITRO AND TRIED TO USE ANOTHER WIRE TO LOCATE THE SIDE BRANCH BUT FAILED. NO PT INJURY OCCURRED AND NO CLINICAL SEQUELAE WERE REPORTED. PROCEDURAL IMAGES WERE PROVIDED FOR REVIEW. THE IMAGES CONFIRM THAT THE TARGET LESION IN THE MAIN BRANCH OF THE LCX WAS PRE-DILATED ON AT LEAST TWO OCCASIONS FOLLOWED BY THE DEPLOYMENT OF THE STENT. THE TARGET LESION APPEARED TO BE PARTIALLY RESISTANT TO BALLOONING BUT TREATMENT WAS SUCCESSFUL IN RESTORING THE LUMEN THROUGH THE LESION. THE PROXIMAL END OF THE INTEGRITY STENT WAS DEPLOYED ACROSS THE OSTIUM OF THE SIDE BRANCH. THE ANGIOGRAPHIC IMAGES PROVIDED FOR REVIEW SHOWED THE LCX AFTER STENTING AND POST DILATATION AND CONFIRMED THAT THE SIDE BRANCH WAS NO LONGER EVIDENT. TREATMENT OF THE PT WITH NITRO FAILED TO RE-ESTABLISH THE VESSEL. IT WAS NOT POSSIBLE TO RE-WIRE THE SIDE-BRANCH WITH A SECOND WIRE. NO FURTHER PT TREATMENT WAS COMPLETED AFTER THE UNSUCCESSFUL RE-ESTABLISHMENT OF THE SIDE BRANCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY RX CORONARY STENT SYSTEM MAF MEDTRONIC CARDIOVASCULAR GALWAY NA 0002385356

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention