BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2172666 · Received July 20, 2011

    Report

    Report Number
    9612164-2011-00776
    Event Type
    Death
    Date Received
    July 20, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 6, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: HAEMORRHAGE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED A TRANSFUSION DURING THE PREVIOUSLY REPORTED GI BLEED EVENT.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE PROX LAD. PT WAS ASYMPTOMATIC AT 30 DAY, 3 MONTH AND 6 MONTH FOLLOW-UPS. APPROXIMATELY 11.5 MONTHS POST INDEX PROCEDURE, THE PT WAS RE-HOSPITALIZED WITH SYMPTOMS OF JAUNDICE, EXPLORATORY LAPAROTOMY SHOWED PANCREAS CANCER. SEVEN DAYS LATER, A GASTRO-INTESTINAL (GI) BLEED OCCURRED. NO TREATMENT WAS GIVEN. SEVEN DAYS LATER THE PT DIED. IT IS REPORTED THAT THE BLEEDING CONTRIBUTED TO THE DEATH. CAUSE OF DEATH: PANCREATIC CANCER. THE INVESTIGATOR INDICATED THAT THE GI BLEED AND PT DEATH WERE NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0000912059

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| H| R ACE INHIBITOR| LIPID LOWERING DRUGS CLOPIDOGREL| AND ASA AT TIME OF EVENT.| THE PT WAS TAKING BETA-BLOCKERS