BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2003626 · Received February 23, 2011

    Report

    Report Number
    2953200-2011-00485
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 25, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THERE WERE 3 ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS IMPLANTED OVERLAPPING IN THE DISTAL RCA. IT IS REPORTED THAT THE FINAL ANGIOGRAPHY SHOWED A DISSECTION JUST PRIOR TO PROXIMAL EDGE OF THE LAST STENT. THE DISSECTION WAS BALLOONED AND AN ENDEAVOR STENT WAS IMPLANTED TO TREAT THE DISSECTION. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY STENT AND PROBABLY RELATED TO THE STUDY PROCEDURE. (REF MFR #S 2953200-2011-00484 AND 2953200-2011-00486).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention