BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1910083 · Received November 10, 2010

    Report

    Report Number
    2024168-2010-02408
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATED DATE OF OCCURRENCE. EVAL SUMMARY: STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO: IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MFR, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREPARATION, AND INTERACTION WITH THE LESION AND/OR ACCESSORY DEVICES. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE LESION CHARACTERISTICS AND PT ANATOMICAL MORPHOLOGY WERE NOT DESCRIBED IN THE INCIDENT INFO, AND MAY HAVE AIDED IN THE EVAL. THERE IS LIMITED CASE INFO AVAILABLE AT THIS TIME AND IT IS UNK WHEN THE STENT DISLODGED. HOWEVER, THERE WAS NO REPORT OF ANY DAMAGE TO THE STENT DELIVERY SYSTEM (SDS) OR STENT IMPLANT PRIOR TO USE, SUGGESTING THAT THE STENT DISLODGEMENT MAY HAVE BEEN A RESULT OF THE PROCEDURE. ALTHOUGH A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE REPORTED STENT DISLODGEMENT, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL SDS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT DISLODGED. THE PHYSICIAN DID NOT RECALL ANY DETAILS ABOUT THE CASE, AND REFUSED TO OBTAIN ANY INFO. THE BOSTON SCIENTIFIC REP WENT INTO THE LAB ASKING FOR FURTHER INFO, BUT THE LAB STAFF DID NOT RECALL AND DID NOT WANT TO LOOK INTO THE ISSUE. NO PT EFFECTS WERE REPORTED. NO ADDITIONAL INFO WAS PROVIDED. YOU ARE RECEIVING THIS MDR FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORP DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK