BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1933501 · Received December 20, 2010

    Report

    Report Number
    2024168-2010-02837
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 25, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    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. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2007 THE PATIENT UNDERWENT STENTING IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH ONE 3.0 X 18 XIENCE V STENT. ON (B)(6) 2010 THE PATIENT EXPERIENCED ANGINA AND A HEADACHE. ON (B)(6) 2010 THE PATIENT UNDERWENT ADDITIONAL STENTING IN THE NON-TARGET LESION IN THE FIRST DIAGONAL BRANCH ARTERY WITH A PROMUS STENT AND THE INDEX LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH A PROMUS STENT. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 70228P6

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R