BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1181157 · Received September 30, 2008

    Report

    Report Number
    9616099-2008-02366
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 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 PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT. THE DEVICE HAS BEEN RECEIVED AND AN ANALYSIS IS PENDING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A MALE PATIENT WAS ADMITTED FOR CORONARY ANGIOGRAPHIC EVALUATION, WHICH REVEALED A 90% NON-CALCIFIED LESION IN THE MID-LAD. PREDILATION WAS CONDUCTED WITH A 3.25 X 18MM HIRYU BALLOON. A 3.0 X 18MM WAS REMOVED FROM THE PACKAGING WITHOUT DIFFICULTIES. THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. A 1:1 MIXTURE OF SALINE AND CONTRAST WAS USED. THE DEVICE WAS ADVANCED THROUGH THE HEMOSTASIS VALVE, THROUGH THE VESSEL AND ACROSS THE TARGET SITE WITHOUT DIFFICULTY. THE 3.0 X 18MM CYPHER STENT WAS THEN DEPLOYED; HOWEVER, THE BALLOON RUPTURED AT 12ATMS. THE PHYSICIAN VISUALIZED CONTRAST MEDIUM LEAKAGE AND THE DEVICE WOULD NOT HOLD PRESSURE. THE STENT WAS DEPLOYED WITHIN THE TARGET. TO ENSURE COMPLETE EXPANSION, THE STENT WAS POST-DILATED WITH THE SAME BALLOON USED FOR PRE-DILATION. THE PROCEDURE WAS COMPLETED SAFELY AND THERE WAS NO REPORTED PATIENT INJURY.

    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 13392941

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 3.25 X 10MM HIRYU BALLOON CATHETER| ABBOTT INFLATION DEVICE| HEARTRAIL GUIDING CATHETER| SHEATH INTRODUCER WAS UNKNOWN| RUNTHROUGH GUIDEWIRE