BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1022096 · Received March 25, 2008

    Report

    Report Number
    9616099-2008-00773
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ADD'L TESTING. ADD'L INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING AN ANIMAL CASE, LEAKAGE WAS OBSERVED AT THE DISTAL PART OF THE BALLOON OF A 2.5 X 18MM CYPHER SELECT PLUS STENT, UNABLE TO MAINTAIN PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA 13338030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA