BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2841930 · Received November 21, 2012

    Report

    Report Number
    2024168-2012-07361
    Event Type
    Death
    Date Received
    November 21, 2012
    Date of Event
    July 23, 2012
    Report Date
    October 31, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE RX XIENCE V 3.0 X 18 MM STENT MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA, CARDIAC ARREST, DEATH, RESPIRATORY DISTRESS, THROMBOSIS, AND VENTRICULAR FIBRILLATION ARE LISTED IN THE (B)(4) XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS. 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 A 3.0X28 XIENCE V RX STENT HAD BEEN IMPLANTED IN THE RIGHT CORONARY ARTERY AT AN UNSPECIFIED DATE AND A 3.0X18 XIENCE V RX HAD BEEN IMPLANTED IN A CONCENTRIC LESION IN THE TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY IN (B)(6) 2010. A LEFT VENTRICULAR EJECTION FRACTION (LVEF) TEST PERFORMED (B)(6) 2012 YIELDED A NORMAL RESULT OF 69%. ON (B)(6) 2012, THE PATIENT PRESENTED WITH 90% IN-STENT RESTENOSIS IN A 2.6X25 SIZED LESION OF THE 3.0X18 XIENCE V RX STENT PLACED IN THE PROXIMAL LAD. A HEPARIN DOSE OF 11000 UNITS WAS ADMINISTERED TO THE PATIENT, THEN THE RESTENOSIS WAS TREATED VIA AN UNSPECIFIED BALLOON DILATATION CATHETER, FOLLOWED BY PLACEMENT OF A 3.0X24 NON-ABBOTT STENT, WITH A RESULT OF TIMI 3 FLOW. THE PATIENT WAS RELEASED FROM THE HOSPITAL (B)(6) 2012. ON (B)(6) 2012 AT 14:00 HOURS, THE PATIENT HAD BEEN REPORTEDLY EXPERIENCING BREATHING DIFFICULTY AND ANGINA, AND ARRIVED IN AN UNCONSCIOUS STATE. THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION, AND DESPITE UNSPECIFIED REVIVAL ATTEMPTS, SUDDEN CARDIAC ARREST OCCURRED AND THE PATIENT EXPIRED ON THE SAME DAY AT 16:26 HOURS. THE PHYSICIAN INDICATED THAT THOUGH THE PROBABLE CAUSE OF DEATH WAS SUDDEN CARDIAC ARREST, THAT THERE EXISTS A PROBABILITY OF THROMBUS FORMATION, THERE IS A POSSIBILITY OF CORRELATION BETWEEN THE DEPLOYED STENT AND DEATH, AND THERE EXISTS THE POSSIBILITY THAT THE IMPLANTED STENT MAY NOT HAVE BEEN PROPERLY DILATED. 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 81 YR Death| H| R STENT: RX XIENCE V 3.0 X 18 MM