BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 5037039 · Received August 27, 2015

    Report

    Report Number
    2024168-2015-04919
    Event Type
    Death
    Date Received
    August 27, 2015
    Date of Event
    July 20, 2014
    Report Date
    August 27, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    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. CONCOMITANT MEDICAL PRODUCTS: OTHER: ASPIRIN 100MG/DAY AND CLOPIDOGREL 75MG/DAY. STENT: 3.5X38MM XIENCE PRIME. (B)(4). THE STENT REMAINS IN THE PATIENT. THE DEVICE WAS NOT RETURNED AND THERE WAS NO DEVICE MALFUNCTION. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE CAUSE FOR THIS INCIDENT. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. DEATH IS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, A 3.5X38MM XIENCE PRIME STENT WAS IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY LESION (RCA), CHRONICALLY OCCLUDED LESION AND ANOTHER 3.5X38MM XIENCE PRIME STENT WAS IMPLANTED IN THE MID TO DISTAL RCA, CHRONICALLY OCCLUDED LESION. DURING A FOLLOW-UP PHONE CALL, ADDITIONAL INFORMATION WAS OBTAINED THAT THE PATIENT EXPIRED AT HOME ON (B)(6) 2014. THE CAUSE OF THE DEATH IS UNKNOWN AND AN AUTOPSY WAS NOT PERFORMED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569085 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2101541

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death