BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2231297 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06075
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 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 DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. THE PATIENT ANATOMY WAS HEAVILY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE FAILURE TO ADVANCE. FACTORS THAT MAY CONTRIBUTE TO STENT FRACTURES INCLUDE, BUT ARE NOT LIMITED TO, PROCESSING AND/OR HANDLING IN MANUFACTURING, HANDLING DURING PREPARATION FOR USE, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, PRODUCT SIZE SELECTION, SEVERE TORQUING OR KINKING OF STENT (MATERIAL STRESS/ FATIGUE) OR INTERACTION WITH THE ACCESSORY DEVICES, LESION AND/OR ANATOMY. THE PATIENT ANATOMY WAS HEAVILY CALCIFIED WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT IS POSSIBLE THAT AN INTERACTION WITH THE HEAVILY CALCIFIED LESION CONTRIBUTED TO THE STENT BREAKING; HOWEVER, THIS COULD NOT BE CONFIRMED. A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE LOT HISTORY RECORD INDICATED NO NONCONFORMING MATERIAL RECORDS FOR THE LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE INDICATED NO OTHER INCIDENTS. BASED ON THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE IN THE HEAVILY CALCIFIED LEFT CIRCUMFLEX ARTERY, PRE-DILATATION WAS PERFORMED MULTIPLE TIMES. A 2.5 X 12 MM PROMUS RX STENT SYSTEM (LOT #0052661) WAS ADVANCED INTO THE PATIENT ANATOMY AND WAS UNABLE TO CROSS THE LESION. THE STENT SYSTEM WAS REMOVED FROM THE PATIENT ANATOMY AND A SECOND 2.5 X 15 MM PROMUS RX STENT SYSTEM WAS THEN ADVANCED INTO THE PATIENT ANATOMY AND THE STENT BROKE. IT IS UNKNOWN IF THE STENT FRACTURED INTO TWO PIECES; HOWEVER, THE STENT DID NOT BECOME DISLODGED. THE PROCEDURE WAS COMPLETED WITH A NEW SAME SIZE NON-ABBOTT STENT SYSTEM. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE PATIENT EFFECTS. ALTHOUGH REQUESTED, 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 0090961

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other