BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3011577 · Received March 19, 2013

    Report

    Report Number
    2024168-2013-01585
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEAVILY CALCIFIED, MILDLY TORTUOUS, LEFT ANTERIOR DESCENDING ARTERY AND GRAFT STENTING PROCEDURE, AFTER PRE-DILATATION WITH A 2.0 X 15 MM NON-ABBOTT BALLOON TO 6 ATMOSPHERES TWO TIMES, AN A XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED INTO THE PATIENTS ANATOMY MEETING RESISTANCE. DURING REMOVAL THE PHYSICIAN FELT A DISTINCT "GIVE AND THE STENT DISLODGED FROM THE SDS. A NON-ABBOTT BALLOON DILATATION CATHETER WAS ADVANCED IN ORDER TO TRY AND SNARE THE DISLODGED STENT. THE UNSPECIFIED GUIDE WIRE, THE NON-ABBOTT BDC, THE UNSPECIFIED GUIDING CATHETER, AND THE STENT WERE ATTEMPTED TO BE REMOVED AS ONE UNIT PER THE INSTRUCTIONS FOR USE AND AS THEY WERE PULLING THROUGH THE INTRODUCER SHEATH, THE STENT DISLODGED FROM THE NON-ABBOTT BDC AND FREE FLOATED TO THE FEMORAL ARTERY. THE STENT IS SUSPECTED TO BE IN THE POPLITEAL ARTERY AT THE PRESENT TIME. THE LESION WAS SUCCESSFULLY TREATED WITH A XIENCE V 2.5 X 23MM STENT. THE PATIENT IS STILL IN THE HOSPITAL AND AFTER A CONSULTATION BETWEEN THE PATIENT AND THE SURGEON, THERE IS NO FOLLOW-UP SURGERY PLANNED AT THIS TIME. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114004 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2032241

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other| R