BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1913336 · Received November 11, 2010

    Report

    Report Number
    2024168-2010-02429
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 19, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO: IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, 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. THERE WAS NO REPORT OF ANY DAMAGE TO THE STENT DELIVERY SYSTEM 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A STENT DISLODGEMENT, HOWEVER; THERE WAS NO REPORTED PT INJURY. THE PHYSICIAN DID NOT RECALL ANY SPECIFIC CASE DETAILS, AND REFUSED TO OBTAIN THE INFO. THE ACCOUNT REP WENT INTO THE CATH LAB TO TRY AND GET FURTHER INFO. THE CATH LAB STAFF DID NOT RECALL AND DID NOT WANT TO LOOK INTO THIS ISSUE TO OBTAIN INFO FOR REP. NO FURTHER INFO IS AVAILABLE ON THIS EVENT. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE UNITED STATES.

    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