BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1032322 · Received April 21, 2008

    Report

    Report Number
    9616099-2008-01050
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    December 3, 2007
    Report Date
    March 28, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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 IN THE SAME PT REPORTED UNDER MANUFACTURING NUMBERS 9616099-2008-01048, 9616099-2008-01049 AND 9616099-2008-01050. PT CODE #2200 - INSUFFICIENT FLOW. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE CLINICAL STUDY REGISTRY INDICATING THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A PT'S IMPLANTED STENTS HAD TO BE POST DILATED FOR HYPOPERFUSION. THE PROCEDURE WAS STAGED FOR CARDIOVASCULAR SAFETY. THE MAIN INDICATION FOR THE PROCEDURE WAS STABLE ANGINA. THE TARGET VESSEL WAS THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) DESCRIBED AS 3.5 X 69MM LONG, DE NOVO, NOT OSTIAL, NO MAJOR SIDE BRANCH INVOLVEMENT, A TYPE C CLASSIFICATION AND TOTAL OCCLUSION. THE VESSEL WAS PREDILATED AT 16 ATMS AND THREE CYPHER STENTS WERE IMPLANTED AT 16 ATMS EACH. EACH STENT WAS ALSO POST DILATED WITH 3.5 X 15MM BALLOON AT 16 ATMS FOR INSUFFICIENT FLOW. NO PROCEDURAL COMPLICATIONS WERE REPORTED AND THE PT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN, CLOPIDOGREL, ANTIDIABETICS, STATINS AND BETA-BLOCKERS. THE PT WAS ASYMPTOMATIC AT THE ONE MONTH FOLLOW UP BUT RETURNED FOR THE PLANNED STAGE PROCEDURE TO TREAT THE RIGHT CORONARY ARTERY. THE 35% STENOSIS (LUMINAL NARROWING) OF THE PREVIOUSLY STENTED MID (LAD) WAS NOTED. NO TREATMENT WAS CONDUCTED.

    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 13275417

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention 2.5 X 15MM UNK BALLOON| 3.5 X 15MM UNK BALLOON