BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1003560 · Received February 25, 2008

    Report

    Report Number
    9616099-2008-00443
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    January 30, 2008
    Report Date
    January 30, 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 MANUFACTURER REPORT NUMBERS ARE 9616099-2008-00442, 9616099-2008-00443 AND 96160099-2008-00444. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT HAD A 50% LESION IN THE MID RIGHT CORONARY ARTERY. THE LESION HAD RESTENOSIS OF TWO CYPHER STENTS THAT HAD BEEN PREVIOUSLY IMPLANTED (3.5 X 23MM AND 3.0 X 33MM). THE VESSEL WAS NOT CALCIFIED OR TORTUOUS. WHILE INFLATING A 3.5 X 8MM CYPHER STENT AT THE LESION, CONTRAST MEDIUM LEAKAGE WAS OBSERVED AT 12 ATM, IN THE MIDDLE OF THE SHAFT, VIA CORONARY ANGIOGRAPHY. THE STENT DELIVERY SYSTEM WAS INFLATED UP TO 16 ATM AND THE DIAMETER OF THE STENT WAS EXPANDED TO AROUND 3MM. THEREFORE, THE STENT DELIVERY SYSTEM WAS REMOVED AND POST-DILATION WAS CONDUCTED AND THE STENT WAS SAFELY IMPLANTED.

    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 I1206079

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization| L| R