BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2781205 · Received October 10, 2012

    Report

    Report Number
    2024168-2012-06390
    Event Type
    Death
    Date Received
    October 10, 2012
    Date of Event
    June 24, 2011
    Report Date
    September 18, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND DEATH ARE LISTED IN THE (B)(6) XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. IT SHOULD BE NOTED THAT THE IFU (PURPOSE OF USE SECTION) STATES: XIENCE V IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO (NEW) NATIVE CORONARY ARTERY LESIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) - INDICATIONS FOR USE. THE STENT REMAINS IN THE PATIENT. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THREE NON-ABBOTT STENTS WERE IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NON-ABBOTT STENTS WERE IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY, RIGHT POSTERIOR DESCENDING ARTERY, AND POSTEROLATERAL SEGMENTAL ARTERY ON (B)(6) 2008. ON (B)(6) 2010, STENOSIS WAS OBSERVED IN THE POSTEROLATERAL SEGMENTAL ARTERY. ON (B)(6) 2010, A XIENCE V STENT WAS IMPLANTED IN THE POSTEROLATERAL SEGMENTAL ARTERY. ON (B)(6) 2011, THE PATIENT DIED. REPORTEDLY, THE CAUSE OF DEATH IS UNKNOWN. NO ADDITIONAL INFORMATION WAS 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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death STENT: TAXUS EXPRESS 2 (NUMBER UNK)| STENT: TAXUS EXPRESS 2 (X3)