BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1953126 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00115
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, CH
    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. EVALUATION SUMMARY: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD IN THE GUIDE WIRE LUMEN. THERE WAS GREEN CONTRAST IN THE INFLATION LUMEN AND BALLOON. THE STENT IMPLANT WAS DISLODGED AND NOT RETURNED. THE BALLOON WAS LOOSELY FOLDED. THERE WERE FAINT CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE TIP LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. THE LESION CONDITION WAS DESCRIBED AS HEAVILY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE FAILURE TO CROSS. ANALYSIS OF THE RETURN PRODUCT NOTED BLOOD IN THE GUIDE WIRE LUMEN AND GREEN CONTRAST IN THE INFLATION LUMEN AND BALLOON. THIS IS CONSISTENT WITH PREPARATION AND A GUIDE WIRE LOADED INTO THE LUMEN. ADDITIONALLY, THE GREEN CONTRAST SUGGESTS THE INDEFLATOR USED DURING THE PROCEDURE MAY HAVE BEEN RE-STERILIZED. DIMENSIONAL ANALYSIS FOUND THAT THE TIP LENGTH MET MANUFACTURING CRITERIA. THE STENT IMPLANT WAS DISLODGED AND NOT RETURNED. HOWEVER, THERE WERE FAINT CRIMP MARKS ON THE LOOSELY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. SINCE THE STENT DISLODGMENT WAS NOT REPORTED AS BEING NOTED PRIOR TO OR DURING USE, THIS SUGGESTS A PRODUCT QUALITY DEFICIENCY DID NOT CONTRIBUTE TO THIS FINDING. FURTHER, IT WAS CONFIRMED FROM THE ACCOUNT THAT THE DISLODGEMENT OCCURRED AFTER USE. TO ENSURE THIS IS NOT THE RESULT OF A PRODUCT DEFICIENCY, ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND THERE HAVE BEEN NO RELATED INCIDENTS REPORTED FOR THIS LOT. ADDITIONALLY, ON-LINE TEST DATA FOR THIS LOT SHOWS ALL UNITS PASSED THE MANUFACTURING CRITERIA. THIS SUGGESTS THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. IN THIS CASE, THE FAILURE TO CROSS AND SUBSEQUENT STENT DISLODGEMENT APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE V STENT SYSTEM COULD NOT CROSS THE HEAVILY CALCIFIED LESION. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. DEVICE ANALYSIS REVEALED THAT THE STENT WAS DISLODGED AND NOT RETURNED. ADDITIONAL REPORTED INFORMATION INDICATES THAT THE STENT DISLODGED AFTER USE OUTSIDE THE ANATOMY.

    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 911304Q

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR