BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1153453 · Received September 5, 2008

    Report

    Report Number
    9616099-2008-02163
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 12, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    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. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MFR REPORT NUMBERS ARE 9616099-2008-02161, 9616099-2008-02162 AND 9616099-2008-02163. ADDITIONAL INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FOR A PROCEDURE IN 2008 WITH A 90%, DE NOVO, FLEXED, SLIGHTLY TORTUOUS AND HIGHLY CALCIFIED LESION IN THE MID TO DISTAL RIGHT CORONARY ARTERY. THE LESION WAS PRE-DILATED AND TWO 3.5 X 28 MM CYPHER STENTS WERE IMPLANTED, OVERLAPPING EACH OTHER. CORONARY ANGIOGRAPHY WAS CONDUCTED AND THE OVERLAPPING SECTION LOOKED UNDER-DILATED. THEREFORE, AN INTRAVASCULAR ULTRASOUND WAS CONDUCTED AND THERE WAS A FRACTURE CONFIRMED IN THE OVERLAPPING PORTION OF THE TWO CYPHERS. THE PHYSICIAN THEN DECIDED TO IMPLANTED A 3.5 X 13 MM CYPHER IN OVERLAPPING PORTION, INSIDE OF THE INITIALLY IMPLANTED CYPHERS. WHEN POST-DILATION WAS BEING CONDUCTED WITH THE STENT DELIVERY SYSTEM BALLOON, THE PHYSICIAN CONFIRMED A BALLOON RUPTURE, AS CONTRAST WAS LEAKING FROM THE BALLOON. HOWEVER, THE CYPHER WAS SUFFICIENTLY IMPLANTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PHYSICIAN COMMENTED THAT THE STENT FRACTURE WAS PROBABLY DUE TO THE OVERLAPPING STENTS IN A FLEXED VESSEL. THE POSSIBLE REASON FOR THE BALLOON RUPTURE COULD HAVE BEEN BECAUSE THE CYPHER WAS CAUGHT ON THE STRUTS OF THE INITIALLY IMPLANTED CYPHERS.

    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 13415881

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention A TGV GUIDEWIRE| AN NC MERCURY BALLOON CATHETER| A 6F BRITE TIP GUIDING CATHETER