BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1023551 · Received March 31, 2008

    Report

    Report Number
    9616099-2008-00818
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADD'L INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED FOR A PROCEDURE IN 2008 WITH A DE NOVO AND HEAVILY CALCIFIED, 99 % LESION IN THE MID LEFT ANTERIOR DESCENDING BRANCH. THE VESSEL WAS HIGHLY TORTUOUS AND HIGHLY FLEXED. PRE-DILATION WAS THOROUGHLY CONDUCTED. THEN PHYSICIAN TRIED TO DELIVER A 2.5 X 18MM CYPHER TO THE TARGET LESION, BUT HE HAD DIFFICULTY DELIVERY IT AND THE STENT STRUTS BECAME FLARED AT THE DISTAL EDGE; THE CYPHER FAILED TO CROSS. THEREFORE, THE PHYSICIAN MANAGED TO DELIVERY A TAXUS STENT FOR IMPLANT ALTHOUGH THERE WAS DIFFICULTY CROSSING AGAIN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PT INJURY REPORTED. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE.

    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 13321614

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK