BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1953017 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00097
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    June 10, 2010
    Report Date
    December 15, 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. THE 2.5 X 18 MM XIENCE (1009551-18/60617P3/268), IS BEING FILED UNDER A SEPARATE MFR#.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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 PATIENT UNDERWENT STENTING IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH ONE 2.5 X 18 XIENCE V STENT, THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA) WITH ONE 2.5 X 18 XIENCE V STENT, AND THE MID RIGHT CORONARY ARTERY WITH ONE 2.5 X 18 XIENCE V STENT. ON (B)(6) 2010, THE PATIENT EXPERIENCED ANGINA THAT WAS TREATED WITH DIAGNOSTIC CORONARY ANGIOGRAPHY AND CORONARY ARTERY BYPASS GRAFT IN THE LAD AND RPDA. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010 UPON DISCHARGE. 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 60609P1

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| S STENT: 2.5 X 18 MM XIENCE ((B)(4))