BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1959221 · Received January 12, 2011

    Report

    Report Number
    2024168-2011-00256
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    December 21, 2009
    Report Date
    December 18, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STENT: XIENCE V 2.5 X 18 MM (PART#1009539-18/LOT#8071661); 3.5 X 15 MM XIENCE V (PART#1009542-15/LOT#8072161). ANGIO-SEAL. THE XIENCE V 2.5 X 18 MM (PART#1009539-18/LOT#8071661) AND 3.5 X 15 MM XIENCE V (PART#1009542-15/LOT#8072161) ARE BEING FILED UNDER SEPARATE MANUFACTURER REPORT NUMBERS. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, MYOCARDIAL INFARCTION (MI), AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ADDITIONALLY, ANGINA, MI, EKG/ECG CHANGES, ELEVATED ENZYMES, RESTENOSIS, TREATMENT WITH MEDICATION, SURGICAL PROCEDURE, AND HOSPITALIZATION ARE LISTED IN THE RISK ASSESSMENT MATRIX (RAM (B)(4) REVISION E) AS NO-FAULT COMPLICATIONS. THOUGH 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

    IT WAS REPORTED VIA TRIAL, THAT ON (B)(6) 2008 THREE XIENCE V STENTS WERE IMPLANTED. A 3.5X15 WAS PLACED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD) AND A 2.5X18 AND 3.5X28 WERE PLACED IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). ON (B)(6) 2009 THE PATIENT EXPERIENCED ANGINA UNRELIEVED BY NITROGLYCERIN AND DIAGNOSED AS A NON Q WAVE MYOCARDIAL INFARCTION. THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT ON (B)(6) 2009 FOR 90% STENOSIS IN THE LAD, 50% STENOSIS IN THE CIRCUMFLEX AND 85% STENOSIS IN THE RCA. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2009 AND THE PATIENT WAS DISCHARGED TO HOME. THOUGH 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 8051341

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R| S