BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1456968 · Received June 19, 2009

    Report

    Report Number
    9616099-2009-01001
    Event Type
    Malfunction
    Date Received
    June 19, 2009
    Date of Event
    May 18, 2009
    Report Date
    June 15, 2009
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT, IS DISTRIBUTED OUTSIDE THE UNITED STATES, BUT IS SIMILAR TO US DISTRIBUTED STENT DELIVERY SYSTEMS. THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. PLEASE NOTE THAT THE INITIAL MEDWATCH REPORT FOR THIS PRODUCT, SENT UNDER MANUFACTURING REPORT NUMBER 9616099-2009-000950 ((B)(4), (B)(4)), WAS ONE OF FIVE REPORTED HUB CRACKS OCCURRING IN THE SAME SINGLE PROCEDURAL SETTING. ADDITIONAL INFORMATION RECEIVED ON JUNE 15, 2009, FROM THE REPORTING AFFILIATE INDICATES THAT EACH OF THE FIVE HUB CRACKS EACH OCCURRED IN DIFFERENT PROCEDURAL SETTINGS AND PATIENTS. BASED ON THIS NEW INFORMATION, A NEW SERVICE REQUEST FILE AND AN INITIAL MEDWATCH REPORT HAS BEEN CREATED FOR THIS PRODUCT. THIS PRODUCT IS NOW BEING REPORTED HERE UNDER CURRENT MFR NUMBER ((B)(4)). NO FURTHER UPDATES WILL BE FORTHCOMING UNDER MANUFACTURING REPORT NUMBER 9616099-2009-000950.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT THE CYPHER SDS WAS UNABLE TO BE DEPLOYED DUE TO A CRACK IN THE HUB. THE CRACK WAS NOTED IN THE UNIT AFTER CROSSING THE LESION AND BEING UNABLE TO DEPLOY THE STENT. THERE WAS NO REPORT OF PATIENT INJURY. ADDITIONAL PATIENT AND PROCEDURAL DETAILS HAVE BEEN REQUESTED, BUT HAVE NOT YET BEEN FORTHCOMING.

    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 14044898

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK