BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1973286 · Received January 28, 2011

    Report

    Report Number
    2024168-2011-00542
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 5, 2011
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. DIL CATH: VOYAGER 2.0 X12. GUIDE WIRE: HI-TORQUE FLOPPY. GUIDE CATH: GUIDELINER. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD ON THE DISTAL SHAFT AND IN THE GUIDE WIRE LUMEN, WHICH IS CONSISTENT WITH LOADING A GUIDE WIRE INTO THE LUMEN AND ADVANCEMENT INTO THE BODY. IT WAS CONFIRMED THAT THE STENT IMPLANT WAS RETURNED DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS). THE BALLOON WAS TIGHTLY FOLDED WITH CRIMP MARKS BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE FIRST TWO ROWS OF THE DISTAL END OF THE STENT IMPLANT WERE STRETCHED PROXIMALLY AND THE PROXIMAL BALLOON TAPER WAS WRINKLED. THE PROXIMAL AND MIDDLE MEASUREMENTS MET MANUFACTURING CRITERIA; HOWEVER, DUE TO THE STENT DAMAGE, THE DISTAL MEASUREMENTS WERE NOT TAKEN. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION AS BEING OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE, IT IS MOST LIKELY THAT IT OCCURRED DURING THE PROCEDURE OR DURING PACKING, HANDLING, AND RETURN TO ABBOTT VASCULAR. 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 PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREP, AND INTERACTION WITH THE LESION, ACCESSORY DEVICES, AND/OR PREVIOUSLY IMPLANTED STENTS. IT IS POSSIBLE THAT AS THE SDS WAS ADVANCED THROUGH THE GUIDELINER, THE STENT IMPLANT BECAME DAMAGED ON THE BALLOON SUCH THAT, WHEN THE SDS WAS RETRACTED, THE STENT DISLODGED AS THE DAMAGED STRUTS INTERACTED WITH THE GUIDELINER; HOWEVER, THIS CANNOT BE CONFIRMED. THE GUIDELINER WAS NOT RETURNED FOR ANALYSIS, WHICH MAY HAVE ASSISTED IN THE INVESTIGATION AND DETERMINATION OF A CAUSE OF THE REPORTED STENT DISLODGMENT. A DEFINITIVE CAUSE OF THE STENT DISLODGMENT CANNOT BE DETERMINED, HOWEVER, THE STENT DAMAGE AND WRINKLED BALLOON TAPER ARE MOST LIKELY RELATED TO OPERATIONAL CONTEXT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ALL STENT DELIVERY SYSTEMS ARE 100% 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ADVANCEMENT OF A 2.5X12 XIENCE V STENT SYSTEM THROUGH A NON-ABBOTT GUIDE EXTENSION IN THE 2ND OBTUSE MARGINAL ARTERY, THE STENT DISLODGED IN THE GUIDE EXTENSION. NO RESISTANCE WAS FELT PRIOR TO STENT DISLODGEMENT. THE GUIDE EXTENSION, STENT DELIVERY SYSTEM, AND GUIDE WIRE WERE REMOVED AS A SINGLE UNIT. A 2.5X12 XIENCE V STENT WAS DEPLOYED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 0091541

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR