BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2063506 · Received April 19, 2011

    Report

    Report Number
    2024168-2011-02751
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 25, 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, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE 3.5X19MM JOSTENT GRAFTMASTER IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. 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 NOT IDENTIFIED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EXPLANTED STENTS INCLUDE, BUT ARE NOT LIMITED TO, INTERACTION OF THE GUIDE WIRE WITH THE STENT IMPLANT IF THE STENT IS NOT FULLY EXPANDED AND APPOSED, THE GUIDE WIRE CAUGHT UNDERNEATH THE IMPLANTED STENT, DAMAGE TO THE STENT, OR INTERACTION WITH OTHER DEVICES. IT IS POSSIBLE THAT ONE OF THE ADDITIONAL DEVICES USED FOR TREATMENT BECAME ENTANGLED WITH THE UNDEREXPANDED GRAFTMASTER STENT AND UPON WITHDRAWAL, THE GRAFTMASTER AND PROMUS STENTS WERE EXPLANTED AND MOVED INTO THE PROXIMAL RIGHT CORONARY ARTERY; HOWEVER, A CONCLUSIVE CAUSE CANNOT BE DETERMINED. THE PRODUCT WAS NOT RETURNED AND MAY HAVE ASSISTED IN THE INVESTIGATION. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES CANNOT BE DETERMINED; HOWEVER, THERE ARE NO INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED. THE LOT HISTORY RECORD WAS NOT REVIEWED BECAUSE THE PRODUCT WAS NOT RETURNED AND THE PART AND LOT NUMBERS ARE UNKNOWN. DURING MANUFACTURING, ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS WAS AN EMERGENCY CASE AT 3:00 A.M. THE GRAFTMASTER DEVICE WAS SELECTED FOR USE TO TREAT AN ANEURYSM IN THE MID RIGHT CORONARY ARTERY (RCA) IN ORDER TO PROTECT THE ANEURYSM DURING TREATMENT OF THE DISTAL RCA. UPON IMAGE REVIEW (POOR QUALITY) THE GRAFTMASTER STENT IN THE MID RCA LOOKED FULLY DEPLOYED. A PROMUS STENT WAS THEN IMPLANTED OVERLAPPING THE EDGE OF THE GRAFTMASTER STENT AND THE DISTAL RCA WAS SUCCESSFULLY TREATED. UPON REVIEW OF THE CASE THE NEXT DAY, ON DIFFERENT IMAGING EQUIPMENT, THE PHYSICIAN REALIZED THAT THE GRAFTMASTER AND THE PROMUS STENT WERE NO LONGER DEPLOYED IN THE MID RCA AND WERE NOW LOCATED IN THE PROXIMAL RCA. IT IS BELIEVED THAT DUE TO THE POOR IMAGE ON THE OLDER EQUIPMENT USED DURING THE PROCEDURE THAT THE GRAFTMASTER STENT WAS UNDEREXPANDED AND THAT THE TREATMENT WITH ADDITIONAL PROMUS BALLOONS AND STENT DELIVERY SYSTEMS GOING IN AND OUT TO TREAT THE DISTAL RCA, PULLED THE UNDEREXPANDED GRAFTMASTER AND THE PROMUS STENT BACK INTO THE PROXIMAL RCA. THE PATIENT WAS STABLE AND WAS TRANSFERRED AT THIS TIME FROM (B)(6) TO (B)(6), WHERE THE MIGRATED GRAFTMASTER WAS DEPLOYED IN THE PROXIMAL RCA (UNINTENDED SITE), AND THE PROMUS STENT WAS SNARED FROM THE ANATOMY. A SECOND GRAFTMASTER WAS SELECTED TO TREAT THE ANEURYSM; HOWEVER, FAILED TO CROSS AND AS ATTEMPTS TO CROSS WITH ADDITIONAL BALLOONS FOR DILATATION ALSO FAILED, THE GRAFTMASTER WAS NOT REINTRODUCED INTO THE ARTERY. 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 67 YR Hospitalization| R 3.5X19MM JOSTENT GRAFTMASTER