BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1972777 · Received January 28, 2011

    Report

    Report Number
    2024168-2011-00502
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT IS 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, ACCESSORY DEVICES, AND/OR PREVIOUSLY IMPLANTED STENTS. RETURN OF THE STENT DELIVERY SYSTEM (SDS) USED IN THE PROCEDURE MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. THE PATIENT ANATOMY WAS REPORTEDLY MODERATELY TORTUOUS AND CALCIFIED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. INTERACTION WITH THE TORTUOUS AND CALCIFIED LESION/ANATOMY DURING ADVANCEMENT IN THE LESION MAY HAVE RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE CAUSED DAMAGE. FURTHER MANIPULATION OF THE SDS WOULD HAVE RESULTED IN THE STENT ULTIMATELY DISLODGING DURING INFLATION. ADDITIONAL TREATMENT WAS USED TO DEPLOY THE STENT AWAY FROM THE TARGET LESION. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE DETERMINED. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR PROPER STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DISTAL LESION IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE 2.5 X 15 MM XIENCE V STENT WAS ATTEMPTED TO BE PLACED IN THE DISTAL SEGMENT; HOWEVER, THE STENT CAME OFF OF THE BALLOON DURING BALLOON INFLATION. THE STENT IMPLANT WAS DEPLOYED AWAY FROM THE TARGET LESION. A SECOND XIENCE V STENT WAS USED IN THE TARGET LESION. THERE WAS NO REPORTED PATIENT SEQUELA. THE PATIENT WAS REPORTED AS DOING FINE AND IS STABLE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0030841

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other STENT: XIENCE V