BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1993850 · Received February 11, 2011

    Report

    Report Number
    2953200-2011-00363
    Event Type
    Death
    Date Received
    February 11, 2011
    Date of Event
    May 27, 2013
    Report Date
    February 17, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    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). RESULTS: (CVA/STROKE).

    Additional Manufacturer Narrative · 1

    EVENT DATE HAS BEEN CONFIRMED AS THE (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS, CONCLUSIONS: INHERENT RISK OF PROCEDURE (DEATH).

    Description of Event or Problem · 1

    A 2.25 MM DIAMETER X 24MM LENGTH AND A 2.5MM DIAMETER X 18MM LENGTH (REF MFR # 2953200-2011-00364) ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT DURING PROCEDURE WERE DEPLOYED IN THE PROX LAD OF A PT WITH NO ISSUE REPORTED. PT WAS ASYMPTOMATIC AT 30 DAY FOLLOW UP; HOWEVER, IT WAS REPORTED THAT HE WAS RE-HOSPITALIZED DUE TO A CVA EVENT APPROX 2 MONTHS POST PROCEDURE. INVESTIGATOR REPORTED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT OR PROCEDURE. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    PREVIOUSLY REPORTED PATIENT DEATH IS REPORTED AS SUDDEN CARDIAC. APPROXIMATELY 31 MONTHS POST INDEX PROCEDURE REVASCULARIZATION OF LCX FIRST DIAGONAL WAS CARRIED OUT AND A BMS WAS IMPLANTED.

    Description of Event or Problem · 1

    APPROXIMATELY 34 MONTHS POST THE INDEX PROCEDURE THE PATIENT HAD A PTCA RELATED TO THE TARGET VESSEL WITH A BALLOON, AND A BMS WAS IMPLANTED. THE OUTCOME WAS SUCCESSFUL. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT.

    Description of Event or Problem · 1

    APPROXIMATELY 35 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS 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 CARDIOVASCULAR GALWAY NA 0000796298

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death| H| R CLOPIDOGREL| LIPID LOWERING DRUG| NITRATE| BETA BLOCKER| ASA| VASTAREL| VERTIXE| ACE INHIBITOR