BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1032336 · Received April 21, 2008

    Report

    Report Number
    9616099-2008-01056
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    February 26, 2008
    Report Date
    April 1, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT WAS TAKEN TO THE ER IN SHOCK AND CORONARY ANGIOGRAM REVEALED THROMBOSIS IN THE CYPHER STENTS IMPLANTED IN THE CFX AND RESTENOSIS OF THE CYPHERS IN THE LAD. THE THROMBOSIS WAS TREATED BY BALLOON ANGIOPLASTY. ACCORDING TO THE PRESIDING PHYSICIAN, MAY HAVE OCCURRED BECAUSE THE DIAMETER OF THE VESSEL WAS TOO SMALL, THE LESION WAS TOO LONG AND THE PT WAS DIABETIC. THIS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE US. HOWEVER, IT IS SIMILAR TO THE US CYPHER SIROLIMUS-ELUTING CORONARY STENT. THIS IS ONE OF FIVE PRODUCTS INVOLVED IN THE SAME PT REPORTED UNDER MFG NUMBERS 9616099-2008-01053, 01054, 01055, 01056 AND 01057. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM ANOTHER COUNTRY INDICATED A PT HAD A THROMBOTIC EVENT TWENTY-SIX MONTHS AFTER IMPLANTATION OF THREE CYPHER STENTS. THE PROCEDURE WAS ELECTIVE AND THE TARGET LESIONS WERE IN THE PROXIMAL TO THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) AND THE PROXIMAL CIRCUMFLEX TO THE FIRST OBTUSE MARGINAL BRANCH (CFX) . THE LESION IN THE LAD WAS DESCRIBED AS 2.3 X 75MM LONG, DE NOVO WITH BIFURCATION AND A TYPE C CLASSIFICATION. IT WAS PREDILATED, PRESSURE UNK, AS THREE 2.5 X 28MM CYPHER STENTS WERE IMPLANTED AT 15 ATMS EACH OVERLAPPING ONE ANOTHER. POST DILATATION WAS NOT CONDUCTED AND THE RESIDUAL STENOSIS WAS ZERO. TIMI FLOW WAS ONE BEFORE THE PROCEDURE AND THREE AFTER THE PROCEDURE. THE CFX WAS DESCRIBED AS 2.6 X 33.5MM LONG, DE NOVO WITH BIFURCATION AND A TYPE C CLASSIFICATION. PRE DILATATION WAS CONDUCTED, PRESSURE UNK, TWO 2.5 X 18MM CYPHER STENTS WERE IMPLANTED AT 15 ATMS EACH. POST DILATATION WAS NOT CONDUCTED AND THE RESIDUAL STENOSIS WAS ZERO. TIMI FLOW WAS ONE BEFORE THE PROCEDURE AND THREE AFTER THE PROCEDURE.

    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 I1005085

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R CLOPIDOGREL| ASPIRIN