BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2232038 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06107
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DIFFICULTY REMOVING THE STENT DELIVERY SYSTEM (SDS) FROM THE STENT IMPLANT POST-DEPLOYMENT MAY BE RELATED TO MANY FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON RUPTURES/LEAKS, POOR BALLOON REFOLD, DEFLATION TECHNIQUE, INTERACTION OF THE BALLOON WITH THE STENT IMPLANT IF THE STENT IS NOT FULLY EXPANDED AND APPOSED, THE BALLOON NOT BEING FULLY DEFLATED PRIOR TO REMOVAL, DAMAGE TO THE STENT, INTERACTION WITH THE PATIENT ANATOMY, OR RESISTANCE WITH THE GUIDE WIRE. TO ENSURE THESE DIFFICULTIES ARE NOT THE RESULT OF MANUFACTURING, THE SDS ARE 100% INSPECTED FOR PROPER BALLOON FOLD CONFIGURATION AND DAMAGE ONLINE, AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED FOR PROPER BALLOON DEFLATION. RETURN OF THE PROMUS SDS MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE AS WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED AND THE LOT NUMBER WAS NOT PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS PERFORMED, AND THE 2.5 X 8 MM PROMUS STENT WAS IMPLANTED SUCCESSFULLY. DURING REMOVAL OF THE STENT DELIVERY SYSTEM, RESISTANCE WAS NOTED WITH THE IMPLANTED PROMUS STENT. IT CONFIRMED THAT THE PROMUS STENT WAS FULLY APPOSED TO THE VESSEL WALL, AND THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: ATLANTIS