BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2031953 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02072
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. STENT DAMAGE CAN OCCUR AS A RESULT OF MULTIPLE THINGS, INCLUDING BUT NOT LIMITED TO: THE MANUFACTURING PROCESS, HANDLING DURING REMOVAL FROM THE PACKAGING AT THE ACCOUNT, HANDLING DURING VISUAL INSPECTION AND/ OR PREPARATION, LOADING ONTO THE GUIDE WIRE AND ACCESSORY DEVICES OR ANATOMICAL CONDITIONS. TO HELP ENSURE THIS DAMAGE IS NOT THE RESULT OF THE MANUFACTURING PROCESS, ALL SDS ARE VISUALLY INSPECTED FOR DAMAGE AT NUMEROUS POINTS IN THE MANUFACTURING PROCESS. THE DEVICE WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS AND THE STENT WAS IMPLANTED. IN THIS CASE, THE PHYSICIAN SUSPECTED THAT THE STENT WAS KINKED; HOWEVER, IT WAS NOT CONFIRMED. THE ANATOMICAL CONDITIONS WERE REPORTED TO BE MILDLY CALCIFIED AND MODERATELY TORTUOUS, WHICH COULD HAVE CONTRIBUTED TO THE APPEARANCE OF STENT DAMAGE. IT IS POSSIBLE THAT THERE MAY HAVE BEEN AN INTERACTION BETWEEN THE STENT AND THE ANATOMICAL CONDITIONS DURING ADVANCEMENT TO THE LESION. ANOTHER STENT WAS IMPLANTED (ADDITIONAL THERAPY/ NON-SURGICAL TREATMENT) TO TREAT THE DISSECTION. FURTHERMORE, DISSECTION IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. THE REPORTED STENT DAMAGE COULD NOT BE CONFIRMED AND A CONCLUSIVE CAUSE AND ITS RELATIONSHIP TO THE REPORTED PATIENT EFFECT, IF ANY, CANNOT BE DETERMINED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. ADDITIONALLY, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING POST-DILATATION OF THE XIENCE V STENT IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY, THE PHYSICIAN NOTICED A DISSECTION AT THE DISTAL EDGE STENT. ANOTHER XIENCE V STENT WAS USED TO COVER UP THE DISSECTION. THE PHYSICIAN SUSPECTED THAT THE STENT WAS KINKED, HOWEVER THIS WAS NOT CONFIRMED. 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 0072041

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention