BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 4098468 · Received September 18, 2014

    Report

    Report Number
    9612164-2014-01214
    Event Type
    Death
    Date Received
    September 18, 2014
    Date of Event
    May 15, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED). (DEATH). (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED). (NONE). DEVICE NOT RETURNED FOR EVALUATION. CONCLUSION: (DEVICE NOT RETURNED). LITERATURE REFERENCE: LONG TERM OUTCOMES OF NEOINTIMAL HYPERPLASIA WITHOUT NEOATHEROSCLEROSIS AFTER DES IMPLANTATION. PRINT ISSN 1936-878X H T T P : / / D X . D O I . O R G / 1 0. 1 0 1 6 / J . J C M G . 2 0 1 4 . 0 5 . 00 4 RECEIVED: MARCH 31 2014 REVISED MANUSCRIPT RECEIVED MAY 12 2014 ACCEPTED MAY 15 2014. DATE ARTICLE WAS ACCEPTED. DATE OF DEATH NOT PROVIDED. DATE CHOSEN IS MID POINT IN THE STUDY.

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED VIA A JOURNAL ARTICLE. STUDY POPULATION CONSISTED OF 336 PATIENTS WITH 368 DES TREATED LESIONS. PATIENTS RECEIVED A FOLLOW-UP OPTICAL COHERENCE TOMOGRAPHY (OCT) WITHOUT ANY INTERVENTION. OCT BASED NEOINTIMA WAS CATEGORIZED AS HOMOGENEOUS (N=227 LESIONS IN 208 PATIENTS), HETEROGENEOUS (N=79 LESIONS IN 73 PATIENTS) OR LAYERED (N=62 LESIONS IN 55 PATIENTS). MAJOR ADVERSE EVENTS WERE ASSESSED ACCORDING TO NEOINTIMAL PATTERNS DURING LONG TERM CLINICAL FOLLOW-UP AFTER OCT EXAMINATION. PATIENTS WERE TREATED WITH 86 SIROLIMUS ELUTING STENTS, 39 PACLITAXEL ELUTING STENTS AND 147 ZOTAROLIMUS ELUTING STENTS (INCLUDING ENDEAVOR SPRINT - ENDEAVOR RESOLUTE) AND 62 EVEROLIMUS ELUTING STENTS. IT IS REPORTED THAT THE CARDIAC DEATH OCCURRED AFTER FOLLOW-UP OCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580438 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death| R