BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1884708 · Received October 25, 2010

    Report

    Report Number
    2024168-2010-02246
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    June 9, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PT EFFECTS OF ANGINA AND RESTENOSIS, AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH CONCLUSIVE CAUSE FOR THE REPORTED PT 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 THAT ON (B)(6) 2006, THE PT UNDERWENT STENTING IN THE PREDILATED MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH ONE XIENCE V STENT. ON (B)(6) 2006, THE PT EXPERIENCED STABLE ANGINA, BUT THERE WAS NO TREATMENT PROVIDED. ON (B)(6) 2010, THE PT EXPERIENCED STABLE ANGINA PECTORIS REQUIRING TREATMENT WITH THREE XIENCE STENTS IN THE PROXIMAL, MID, AND DISTAL LAD WHERE THE STENOSIS WAS FOUND TO BE WITHIN 5 MM OF THE INDEX XIENCE STENT. THE PT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. THERE WAS NO ADVERSE PT SEQUELA. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 60608P1

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R DIL CATH: HINODE