BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2232018 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06106
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    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. SHAFT SEPARATIONS DURING USE MAY OCCUR FROM FACTORS SUCH AS DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING PRIOR TO AND DURING THE PROCEDURE, REMOVAL TECHNIQUE FROM THE PACKAGING, ASSOCIATIVE DEVICE INTERACTION, AND AN INTERACTION WITH THE PATIENT ANATOMY. SINCE THERE WAS NO DAMAGE NOTED TO THE STENT DELIVERY SYSTEM (SDS) DURING INSPECTION PRIOR TO THE PROCEDURE, THIS MAY INDICATE THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED. IT IS POSSIBLE THAT THE SHAFT KINKED DURING THE PROCEDURE IN THE MODERATELY TORTUOUS ANATOMY AND FURTHER MANIPULATION OF THE SDS RESULTED IN THE SHAFT SEPARATING; HOWEVER, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. RETURN OF THE SDS MAY HAVE FURTHER ASSISTED THE EVALUATION IN DETERMINING A CAUSE FOR THE REPORTED SEPARATION. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL MANUFACTURING DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR KINKS AND DAMAGE DURING THE MANUFACTURING PROCESS. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO OTHER INCIDENTS. BASED ON THE INFORMATION RECEIVED WITH THIS INCIDENT AND WITHOUT THE DEVICE TO EXAMINE, A CONCLUSIVE CAUSE OF THE REPORTED SHAFT SEPARATION COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DISTAL RIGHT CORONARY ARTERY PROCEDURE, THE SHAFT OF THE XIENCE STENT DELIVERY SYSTEM SEPARATED RIGHT OUTSIDE THE GUIDING CATHETER WHILE ADVANCING. NO RETRIEVAL METHODS WERE REQUIRED AS THE SEPARATED PORTION COULD EASILY BE REMOVED. ANOTHER SAME-SIZED XIENCE V WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THERE WAS NO ADDITIONAL INFORMATION 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 1051141

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR