BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 1040074 · Received May 7, 2008

    Report

    Report Number
    2953200-2008-00290
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 7, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: MYOCARDIAL INFARCTION, OCCLUSION. LACK OF INFO. CONCLUSION: LACK OF INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO ENDEAVOR STENTS WERE IMPLANTED IN THE MID-LAD (ONE 3.0 X 30 MM STENT AND ONE 2.5 X 18 MM STENT) REF MDR 2953200-2008-00291. ON THE SAME DAY AS IMPLANT, THE PT SUFFERED AN ACUTE NON-STEMI (ANTERIOR INFARCTION). IT WAS REPORTED THAT THE TARGET LESION WAS INVOLVED AND THAT THE EVENT WAS RELATED TO THE STENT. IT WAS REPORTED THAT THE 1ST DIAGONAL VESSEL BECAME OCCLUDED BY THE LAD STENT. THE INVESTIGATOR ASSESSED THE EVENT AS A NON Q-WAVE MI. PLEASE NOTE THAT THIS MODEL NUMBER IS NOT DISTRIBUTED IN THE UNITED STATES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK