BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1946358 · Received January 4, 2011

    Report

    Report Number
    2024168-2011-00010
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 11, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. STENT: OTW XIENCE V ((B)(4)); VESSEL CLOSURE: ANGIO-SEAL. 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) 2010, THE PATIENT UNDERWENT STENTING IN THE PREDILATED PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH ONE 3.5 X 28 XIENCE V STENT, IN THE PREDILATED MID RCA WITH TWO XIENCE V STENTS SIZES 3.5 X 15 AND 3.5 X 12, AND IN THE PREDILATED DISTAL RCA WITH TWO XIENCE V STENTS SIZES 2.5 X 18 AND 3.0 X 23. ON (B)(6) 2010, THE PATIENT EXPERIENCED UNSTABLE ANGINA AT REST AND WITH MINIMAL EXERTION. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION IN THE INDEX PROXIMAL RCA WITH AN ADDITIONAL DRUG ELUTING STENT AND IN THE NON-TARGET POSTERIOR DESCENDING ARTERY WITH ANGIOPLASTY ONLY. 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 9091861

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R (B)(4)