BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1023353 · Received April 1, 2008

    Report

    Report Number
    3003742446-2008-00047
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    January 18, 2008
    Report Date
    March 9, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 TWO PRODUCTS INVOLVED IN THE SAME PT REPORTED UNDER MFG NUMBERS 3003742446-2008-00047 AND 3003742446-2008-00048. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE CORDIS CLINICAL STUDY REGISTRY INDICATING THAT A PT HAD TWO RESTENOSIS EVENTS ON TWO SEPARATE OCCASIONS INVOLVING TWO CYPHER STENTS IMPLANTED APPROX THREE YEARS PRIOR TO THE INDEX PROCEDURE OF THE STUDY. NO INFO REGARDING THE PROCEDURE OR THE VESSEL AND LESION CHARACTERISTICS IS AVAILABLE. HOWEVER, AT THE INDEX PROCEDURE A CYPHER WAS REPORTED IN THE MID RIGHT CORONARY ARTERY AND WAS DESCRIBED AS RESTENOTIC WITH FOCAL IN-STENT RESTENOSIS 2.5MM WIDE WITH A LENGTH EQUAL TO OR LESS THAN 10MM, A TYPE C CLASSIFICATION WITH 95% STENOSIS. THE RESTENOSIS WAS TREATED BY IMPLANTATION OF ANOTHER 2.75 X 13MM CYPHER AT 20 ATMS. THE SECOND RESTENOSED CYPHER IN THE MID LEFT CIRCUMFLEX WAS TREATED TWO DAYS LATER IN A STAGED PROCEDURE PLANNED AT THE INDEX PROCEDURE DUE TO CONTRAST LOAD. IT WAS GREATER THAN 50% STENOSED AND WAS TREATED BY BALLOON ANGIOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention ACE INHIBITOR| CLOPIDOGREL| STATINS| BETA-BLOCKERS| ASPIRIN