BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 6211662 · Received December 28, 2016

    Report

    Report Number
    2024168-2016-09309
    Event Type
    Death
    Date Received
    December 28, 2016
    Date of Event
    September 26, 2016
    Report Date
    December 28, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    08717648176920
    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). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. DEATH IS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT(S) OF CORONARY STENTING PROCEDURES. BASED ON THE INFORMATION REVIEWED, 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, THE PATIENT UNDERWENT A CORONARY PROCEDURE WITH IMPLANTATION OF A 2.25 X 15 MM XIENCE PRIME STENT IN THE POSTERIOR LATERAL BRANCH. ON (B)(6) 2014, (B)(6) 2014 AND (B)(6) 2015, THE PATIENT WAS SEEN FOR FOLLOW UP VISITS. CORONARY ANGIOGRAPHY WAS PERFORMED AND NO IN-STENT RESTENOSIS WAS NOTED. THE PATIENT DID NOT EXPERIENCE ANY ANGINAL SYMPTOMS. ON (B)(6) 2016, INFORMATION WAS RECEIVED, INDICATING THAT THE PATIENT HAD DIED. CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860680 XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2121741 08717648176920

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death