BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2180842 · Received July 21, 2011

    Report

    Report Number
    9612164-2011-00815
    Event Type
    Death
    Date Received
    July 21, 2011
    Date of Event
    April 19, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: REVASCULARIZATION, HEMORRHAGE, DEATH.

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT WAS IMPLANTED TO PROXIMAL RCA DURING THE INDEX PROCEDURE. PT WAS ASYMPTOMATIC AT 1 MONTH F/U. PT HAD CARDIAC STATUS OF STABLE ANGINA AT 6 MONTH, 1 YR AND 1.5 YR F/U. PT WAS ASYMPTOMATIC AT 2 YR F/U. APPROXIMATELY 26 MONTHS POST INDEX PROCEDURE, A REVASCULARIZATION OF THE PROXIMAL RCA WAS PERFORMED. CLINICAL SYMPTOMS FOR INTERVENTION WERE A POSITIVE HISTORY OR RECURRENT ANGINA PECTORIS PRESUMABLY RELATED TO TARGET VESSEL AND OBJECTIVE SIGNS OF ISCHEMIA AT REST OR DURING EXERCISE TEST PRESUMABLY RELATED TO TARGET VESSEL. INVESTIGATOR DESCRIBED LESION AS TARGET LESION AND REPORTED RESTENOSIS AFTER PREVIOUS PTCA. TWO OTHER BRAND STENTS WERE IMPLANTED (OVERLAPPING) DURING REVASCULARIZATION PROCEDURE. PT WAS TAKING ASPIRIN 24 HRS PRIOR TO EVENT. IN THE INVESTIGATOR'S OPINION THE EVENT WAS RELATED TO THE STUDY STENT. APPROXIMATELY 38 MONTHS POST INDEX PROCEDURE A BLEEDING EVENT OCCURRED (SPONTANEOUS GI BLEED). PT WAS ON DAPT AT THE TIME OF THE EVENT. THE PT RECEIVED 3 UNITS OF PRBC. THE INVESTIGATOR REPORTED THAT THERE WAS NO RELATIONSHIP BETWEEN THE GI BLEED AND THE DEVICE/PROCEDURE. APPROXIMATELY 39 MONTHS POST INDEX PROCEDURE THE PT WAS HOSPITALIZED FOR A MESENTERIC EMBOLI, OP EMBOLECTOMY AND PATCH. PT WAS ADMITTED TO THE ICU AND WAS DOING WELL, EXTUBATED, HOWEVER THEN DEVELOPED PROBLEMS WITH O2 STATS. IT WAS REPORTED THAT THE PT DIED. THE PT DEATH WAS ASSESSED AS A NON-SUDDEN, NON-CARDIAC DEATH DUE TO SEPSIS. DEATH WAS NOT ASSOCIATED WITH A MI OR STENT THROMBOSIS. THE INVESTIGATOR REPORTED THAT IT WAS NOT ASSESSABLE WHETHER THE DEATH WAS RELATED TO THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| R ASA| CLOPIDOGREL