BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 970006 · Received December 26, 2007

    Report

    Report Number
    9616099-2007-02603
    Event Type
    Injury
    Date Received
    December 26, 2007
    Date of Event
    October 7, 2007
    Report Date
    November 28, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER IT IS SIMILAR TO THE UNITED STATES PRODUCT. THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFT REPORT #9616099-2007-02602. THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE TARGET LESION WAS NATIVE, RESTENOTIC LESION OF A PREVIOUSLY IMPLANTED PRO-KINETIC BARE METAL STENT LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS NON-OSTIAL, TYPE C, WITH LITTLE TO NO CALCIFICATION. THE REFERENCE VESSEL DIAMETER WAS 3.0MM AND THE LESION LENGTH WAS 18MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 70%. THE LESION WAS NOT PRE-DILATED. A 3.0X33MM CYPHER SELECT PLUS STENT WAS ELECTIVELY IMPLANTED AT 22ATM. POST DILATING WAS CONDUCTED WITH A 3.0X24MM BALLOON AT 6ATM DUE TO INSUFFICIENT FLOW. A DISSECTION WAS NOTED. A 3.0X23MM CYPHER SELECT PLUS STENT WAS THEN IMPLANTED 14ATM WITH SATISFACTORY RESULT. THIS STENT WAS NOT POST-DILATED. POST-PROCEDURE DIAMETER STENOSIS WAS 10%. THREE DAYS POST PROCEDURE, THE PT FELT CHEST PAIN. CORONARY ANGIOGRAPHY SHOWED THROMBOSIS WITHIN THE IMPLANTED STENTS. PT WAS TREATED WITH INTEGRILIN AND BALLOON DILATATION. THE PT HAD ELEVATED TROPONIN T BUT NORMAL CK.

    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 13249506

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R ASPIRIN| CLOPIDOGREL| HEPARIN