BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1972794 · Received January 25, 2011

    Report

    Report Number
    2953200-2011-00171
    Event Type
    Death
    Date Received
    January 25, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (PT WAS VERY UNSTABLE WITH UNSTABLE DISEASE), (HEAVILY DISEASED VESSEL WITH CALCIFICATION AND STENOSIS), (DEATH). CONCLUSION: (HEAVILY DISEASED VESSEL WITH CALCIFICATION AND STENOSIS).

    Description of Event or Problem · 1

    A 3.0MM DIAMETER X 18MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING CORONARY STENT WAS DEPLOYED IN A PT (MFR # 2953200-2011-00169). THE TARGET LESION, LOCATED IN THE CX WAS DESCRIBED AS CALCIFIED AND HEAVILY DISEASED WITH 90% STENOSIS. DURING PROCEDURE, A 2.5MM DIAMETER X 14MM LENGTH AND A 2.5MM DIAMETER X 18MM LENGTH ENDEAVOR SPRINT RX STENTS WERE ALSO DEPLOYED TO TARGET LESION (MFR # 2953200-2011-00170). NO ISSUE WERE REPORTED IN RELATION TO STENT DEPLOYMENT; HOWEVER, IT WAS REPORTED THAT THE PT DIED POST PROCEDURE WHEN THE PHYSICIAN WAS TRYING TO SECURE A BALLOON PUMP. THE PHYSICIAN COMMENTED THAT THE PT WAS VERY UNSTABLE WITH UNSTABLE DISEASE AND THAT THE EVENT WAS NOT RELATED TO THE ENDEAVOR SPRINT RX STENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death