BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2044042 · Received April 7, 2011

    Report

    Report Number
    2024168-2011-02428
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS IN THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF ANGINA, RESTENOSIS, AND MI, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. THE ECG CHANGES AND ENZYME ELEVATION WERE LIKELY SECONDARY TO THE EFFECTS OF THE MI. 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 THAT ON (B)(6) 2008 THE PATIENT UNDERWENT STENTING IN THE PREDILATED PROXIMAL LEFT CIRCUMFLEX ARTERY (PLCX) WITH ONE XIENCE V STENT. ON (B)(6) 2011 THE PATIENT WAS RE-ADMITTED FOR A MYOCARDIAL INFARCTION (MI) WITH SUBSTERNAL CHEST PRESSURE RADIATING TO THE BACK AND UNRELIEVED BY NITROGLYCERIN. THE PATIENT UNDERWENT REVASCULARIZATION ON (B)(6) 2011 IN THE INDEX LESION AND IN THE NON-TARGET VESSEL. THE PATIENT WAS DISCHARGED ON (B)(6) 2011. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THAT THIS EVENT WAS DETERMINED TO BE A SMALL NON Q MI AND THE REVASCULARIZATION WAS TREATING A LESION IN THE PROXIMAL EDGE OF THE XIENCE V STENT IN THE PLCX. 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 8042541

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R| S