BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2101235 · Received May 24, 2011

    Report

    Report Number
    2024168-2011-03671
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT RETURNED AND MAY HAVE AIDED IN THE INVESTIGATION. HOWEVER, POSSIBLE CAUSES FOR SHAFT SEPARATION MAY INCLUDE, BUT ARE NOT LIMITED TO: MANUFACTURING HANDLING AND/OR PROCESSING AND HANDLING DURING UNPACKING OR PREPARATION FOR USE. SHAFT SEPARATIONS ARE OFTEN ATTRIBUTED TO DUCTILE OVERLOAD AT A KINK. KINKS OR BENDS IN THE SHAFT CAN LEAD TO WEAKENING OF THE STENT DELIVERY SYSTEM MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. TO HELP ENSURE THAT THE REPORTED SHAFT DETACHMENT IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY. IT IS POSSIBLE THAT MISHANDLING DURING PREPARATION CONTRIBUTED TO THE SHAFT DETACHMENT; HOWEVER, A CONCLUSIVE CAUSE CANNOT BE DETERMINED. A REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED SHAFT DETACHMENT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR SHAFT DETACHMENT FOR THIS LOT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED SHAFT DETACHMENT CANNOT BE DETERMINED, THERE DOES NOT APPEAR TO BE AN INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHAFT OF THE PROMUS RX STENT DELIVERY SYSTEM (SDS) BROKE DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROMUS SDS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 0051861

    Patients

    Seq Age Sex Outcome Treatment
    1