BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2142934 · Received June 28, 2011

    Report

    Report Number
    2024168-2011-04527
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED, THEREFORE, IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS. HYPOTUBE FRACTURES ARE OFTEN THE RESULT OF DUCTILE OVERLOAD (MATERIAL STRESS/FATIGUE). KINKS OR BENDS IN THE SHAFT CAN LEAD TO WEAKENING OF THE STENT DELIVERY SYSTEM (SDS) MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR KINKS AND DAMAGE. THE DEVICE WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS AND MAY HAVE ASSISTED IN THE INVESTIGATION. IT WAS REPORTED THAT DURING ADVANCEMENT OF THE SDS MID WAY INTO THE GUIDING CATHETER, THE PROXIMAL SHAFT REPORTEDLY SEPARATED OUTSIDE OF THE PATIENT ANATOMY. IT IS POSSIBLE THAT THE HYPOTUBE MAY HAVE BEEN KINKED DURING ADVANCEMENT AND FURTHER HANDLING DURING REMOVAL MAY HAVE CONTRIBUTED TO THE REPORTED HYPOTUBE SEPARATION. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND NO OTHER INCIDENTS HAVE BEEN REPORTED FOR HYPOTUBE SEPARATION FOR THIS LOT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED HYPO TUBE SEPARATION COULD NOT BE DETERMINED, THERE ARE NO INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE 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. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS IN THE MILDLY CALCIFIED CIRCUMFLEX. DURING ADVANCEMENT OF THE 2.5 X 23 MM PROMUS MIDWAY INTO THE GUIDING CATHETER, THE PROXIMAL SHAFT OF THE STENT DELIVERY SYSTEM SEPARATED OUTSIDE THE PATIENT ANATOMY. NO RESISTANCE WAS REPORTED WITH THE GUIDING CATHETER DURING ADVANCEMENT. THE DEVICE NEVER ENTERED THE VESSEL; IT WAS REMOVED FROM THE GUIDING CATHETER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. 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 9122141

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR