BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1953294 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00173
    Event Type
    Death
    Date Received
    January 7, 2011
    Date of Event
    March 3, 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
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO PREDILATATION. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF DEATH AND ISCHEMIA 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) 2008 THE PATIENT UNDERWENT DIRECT STENTING IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH ONE XIENCE V STENT. ON (B)(6) 2010 THE PATIENT HAD ELEVATED CARDIAC ENZYMES AND A POSITIVE FUNCTIONAL ISCHEMIA STUDY; HOWEVER, THE ECG SHOWED NO MYOCARDIAL INFARCTION. ON (B)(6) 2010 THE PATIENT UNDERWENT A DIAGNOSTIC CORONARY ANGIOGRAM WHERE IT WAS FOUND THAT THERE WAS NO IN-STENT RESTENOSIS IN THE INDEX MID LAD AND THERE WAS NO INTERVENTION REQUIRED. ON (B)(6) 2010 THE PATIENT EXPERIENCED ACUTE RESPIRATORY FAILURE AND EXPIRED ON (B)(6) 2010. THE PATIENT WAS GIVEN OXYGEN FOR THE RESPIRATORY FAILURE. 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 7103161

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death