BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1951652 · Received January 6, 2011

    Report

    Report Number
    2024168-2011-00076
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 5, 2010
    Report Date
    December 14, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. VESSEL CLOSURE: BOOMERANG CLOSURE SYSTEM; STENT: XIENCE V 4.0X18. IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). 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) 2009 THE PATIENT UNDERWENT CORONARY ARTERY STENTING WITH ONE 4.0 X 18 MM IN THE DISTAL CIRCUMFLEX AND ONE 2.5 X 12 MM IN THE SECOND OBTUSE MARGINAL, BOTH WERE XIENCE V STENTS. THE PATIENT EXPERIENCED ANGINA AND ON (B)(6)2010 THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY FOR IN-STENT RESTENOSIS OF THE LARGE OBTUSE MARGINAL CORONARY ARTERY INDEX TARGET LESION. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010. THERE WAS NO ADVERSE PATIENT SEQUELA. ALTHOUGH REQUESTED, 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 9081041

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R (B)(4)