BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2143497 · Received June 29, 2011

    Report

    Report Number
    2024168-2011-04557
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. EVALUATION SUMMARY: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITHOUT ANY BLOOD VISIBLE. THERE WAS CONTRAST IN THE INFLATION LUMEN. THIS IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE SDS WAS NOT INSERTED INTO THE BODY AND SUGGESTS PREPARATION. ANALYSIS NOTED THE STENT IMPLANT RETURNED DISLODGED FROM THE SDS. THE BALLOON WAS TIGHTLY FOLDED WITH CRIMP MARKS BETWEEN THE MARKERS SUGGESTING THE STENT WAS PROPERLY PLACED ON THE BALLOON DURING MANUFACTURING. THERE WERE FLARED STRUTS ON THE FIRST ROW OF BOTH ENDS OF THE STENT IMPLANT. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THE OUTER DIAMETERS OF THE STENT IMPLANT WERE MEASURED AND WERE NOTED TO BE OVERSIZED. THE DISTAL EDGE OF THE SOFT TIP WAS JAGGED. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH WAS NOT RETURNED. IT WAS REPORTED THAT WHEN THE SDS WAS ADVANCED OVER THE GUIDE WIRE, A KINK IN THE GUIDE WIRE AND WHEN THE SDS INTERACTED WITH THE KINK THE STENT DISLODGED. IN THIS CASE, THE NOTED OVER SIZED OUTER DIAMETERS OF THE STENT AND JAGGED TIP APPEAR TO BE CONSISTENT WITH HANDLING AS A RESULT OF THE INTERACTION WITH THE KINKED GUIDE WIRE AND SUBSEQUENTLY LED TO THE DISLODGEMENT OF THE STENT. ADDITIONALLY, THE LOT RELEASE TESTING RESULTS WERE REVIEWED AND ALL STENT DISLODGEMENT SAMPLES MET MANUFACTURING CRITERIA. POTENTIAL CAUSES FOR STENT DISLODGEMENT PRIOR TO USE MAY INCLUDE, BUT NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREPARATION FOR USE, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREPARATION FOR USE. TO HELP ENSURE STENT DISLODGEMENT IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL STENT DELIVERY SYSTEMS (SDS) ARE INSPECTED FOR PROPER STENT PLACEMENT AND CRIMPED STENT OUTER DIAMETER. IN ADDITION, AS PART OF PRODUCT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED FOR STENT DISLODGEMENT FORCE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND NO OTHER INCIDENTS HAVE BEEN REPORTED FOR STENT DISLODGEMENT FOR THIS LOT. THE REPORTED STENT DISLODGEMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 2.25 X 28 MM XIENCE NANO RX STENT WAS BEING ADVANCED OVER A NON-ABBOTT WIRE. WHILE STILL OUTSIDE OF THE BODY, THE STENT DELIVERY SYSTEM HIT A KINK IN THE WIRE AND DISLODGED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. A 2.5 X 28 XIENCE V STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION. ALTHOUGH REQUESTED, 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 1022842

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: VOLCANO WIRE