BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS OPTA PRO

    MDR report key: 1081980 · Received July 22, 2008

    Report

    Report Number
    9610978-2008-00187
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FOR A PROCEDURE IN 2008 WITH AN 80% MILDLY CALCIFIED LESION IN THE LEFT COMMON ILIAC ARTERY. A 10 X 29MM PALMAZ GENESIS STENT WAS IMPLANTED IN LESION. AFTER DELIVERING THE STENT, AN ATTEMPT WAS MADE TO CONDUCT ANGIOPLASTY IN ANOTHER PART OF THE VESSEL BUT THE BALLOON BURST AT 9ATM. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS OPTA PRO ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA R0906458

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR