BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2003963 · Received March 1, 2011

    Report

    Report Number
    2024168-2011-01268
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. AS STATED, THE STENT WAS DISCOVERED TO BE DISLODGED AFTER THE STENT DELIVERY SYSTEM (SDS) HAD BEEN ADVANCED TO THE RIGHT CORONARY ARTERY. THE XIENCE V INSTRUCTIONS FOR USE (IFU) STATES: PRIOR TO USING THE DEVICE, CAREFULLY REMOVE THE SYSTEM FROM THE PACKAGE AND INSPECT FOR BENDS, KINKS, AND OTHER DAMAGE. VERIFY THAT THE STENT DOES NOT EXTEND BEYOND THE RADIOPAQUE BALLOON MARKERS. DO NOT USE IF ANY DEFECTS ARE NOTED. FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT PRIOR TO USE INCLUDE, BUT ARE NOT LIMITED TO: IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PRODUCT PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL OR FROM HANDLING OF THE STENT DURING PRODUCT PREPARATION. ANALYSIS OF THE RETURNED PRODUCT CONFIRMED THAT THE STENT IMPLANT WAS RETURNED DISLODGED FROM THE SDS. HOWEVER, CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON AND BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE OUTER DIAMETER OF THE UNDAMAGED STENT IMPLANT AND THE INNER DIAMETER OF THE PROTECTIVE SHEATH MET MANUFACTURING CRITERIA. IT IS POSSIBLE THAT POSITIVE PRESSURE MAY HAVE BEEN APPLIED TO THE SYSTEM AT SOME POINT, CAUSING THE BALLOON TO SLIGHTLY EXPAND, PARTIALLY DEPLOYING THE STENT IMPLANT. THIS WOULD CAUSE THE STENT IMPLANT TO BECOME LOOSE, FACILITATING STENT IMPLANT DISLODGEMENT DURING REMOVAL OF THE PROTECTIVE SHEATH. HOWEVER, THIS CANNOT BE CONFIRMED. TO ENSURE THAT STENT DISLODGEMENT IS NOT A RESULT OF A POTENTIAL MANUFACTURING DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. A SAMPLING OF UNITS IS ALSO SUBJECT TO A STENT MOVEMENT TEST TO VERIFY STENT SECURITY. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A DEFINITIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE RIGHT CORONARY ARTERY, THE PHYSICIAN NOTED THAT THE XIENCE V STENT DELIVERY SYSTEM (SDS) DID NOT HAVE A STENT ATTACHED. THE STENT WAS FOUND IN THE PROTECTIVE SHEATH, WHICH WAS OUTSIDE OF THE BODY. THE SDS WAS THEREFORE REMOVED OUTSIDE OF THE BODY AND REPLACED WITH ANOTHER XIENCE V TO COMPLETE THE PROCEDURE. NO PATIENT EFFECTS WERE REPORTED. 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 0081841

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: RUNTHROUGHGUIDE CATH: GC 6F JR4