BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2193243 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05556
    Event Type
    Death
    Date Received
    August 5, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 13, 2011
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE 2.5 X 15 MM XIENCE V DEVICE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. STENT: 2.5 X 15 MM XIENCE V. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED MYOCARDIAL INFARCTION AND DEATH ARE KNOWN ADVERSE EVENTS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANOMALY WAS NOTED ON ELECTROCARDIOGRAM ON AN UNSPECIFIED DATE. UPON CONSULTATION WITH THE CARDIOVASCULAR DEPARTMENT, NO NOTICEABLE SYMPTOMS WERE OBSERVED. HOWEVER, MULTI-DETECTOR COMPUTERIZED TOMOGRAPHY REVEALED THE LEFT ANTERIOR DESCENDING ARTERY TO BE 75% STENOSED, AND THE DISTAL RIGHT CORONARY ARTERY TO BE 75% STENOSED. ON (B)(6) 2010 CORONARY ANGIOGRAM WAS PERFORMED. THE LEFT ANTERIOR DESCENDING ARTERY WAS 75% STENOSED, WITH A DIFFUSE LESION. ON (B)(6) 2010, PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT DILATATION CATHETER. A 2.5 X 23 XIENCE V RX STENT SYSTEM WAS ADVANCED AND THE STENT WAS DEPLOYED. POST-DILATATION WAS PERFORMED WITH A NON-ABBOTT DILATATION CATHETER. ON (B)(6) 2010 PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED IN THE DISTAL RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT DILATATION CATHETER. A 2.5 X 15 XIENCE V STENT WAS ADVANCED AND THE STENT WAS DEPLOYED. POST-DILATATION WAS PERFORMED WITH A NON-ABBOTT DILATATION CATHETER. ON (B)(6) 2011 THE PATIENT DIED AT HOME. AUTOPSY REVEALED THE PATIENT DIED OF MYOCARDIAL INFARCTION. THOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN 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 0041541

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death