BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1921871 · Received December 13, 2010

    Report

    Report Number
    2024168-2010-02681
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. 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 OR DESIGN.

    Description of Event or Problem · 1

    THE STUDY INDEX PROCEDURE WAS DONE ON (B)(6) 2008 TO TREAT THE MID LEFT ANTERIOR DESCENDING (LAD). THE XIENCE V 2.5 X 28 WAS DEPLOYED WITHOUT AN ISSUE. THE LESION WAS PRE-DILATED PRIOR TO STENTING. THERE WERE NO REPORTED PATIENT EFFECTS AT THE TIME OF THE INDEX PROCEDURE. HOWEVER, ON (B)(6) 2010 THE PATIENT RETURNED WITH ANGINA (B)(6). ANGIOGRAPHY REVEALED RESTENOSIS OF THE MID LAD AND REVASCULARIZATION WAS PERFORMED TO TREAT THE MID LAD WITH AN ADDITIONAL XIENCE V STENT. 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 70226P2

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R