BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1191107 · Received September 26, 2008

    Report

    Report Number
    9616099-2008-02356
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 29, 2008
    Report Date
    August 30, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVAL AND TESTING; HOWEVER, AS OF TO DATE, THE EVAL HAS NOT BEEN COMPLETED. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE PHYSICIAN ENCOUNTERED INFLATION DIFFICULTIES DURING STENT DEPLOYMENT. THE REPORT RECEIVED INDICATED THAT DURING A PROCEDURE TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING, THE LESION WAS SUCCESSFULLY PRE-DILATED AND THE LESION STENOSIS WAS REDUCED TO 50%. INTRAVASCULAR ULTRASOUND WAS CONDUCTED AND THE 3.0X13MM CYPHER STENT WAS BEING ADVANCED; HOWEVER, SOME FRICTION WAS ENCOUNTERED BEFORE REACHING THE TARGET LESION. AFTER THE LESION WAS CROSSED, THE PHYSICIAN DEPLOYED THE CYPHER AT THE TARGET LESION, AND WHILE INFLATING THE BALLOON; THE PRESSURE COULD NOT BE APPLIED HIGHER THAN 6 ATMOSPHERES. THEREFORE, THE PRESSURE WAS RAPIDLY INCREASED AND THE STENT WAS DEPLOYED. THE PROCEDURE WAS FINISHED BY CONDUCTING POST-DILATION WITH ANOTHER BALLOON AND WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND A KINK ON THE SHAFT WAS CONFIRMED. 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 13410497

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR LAUNCHER (6F SL3.5)| 2.5X13MM FORTIS| HIRYU (3.5/10MM)| NEO'S RINATO