BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1053433 · Received May 27, 2008

    Report

    Report Number
    9616099-2008-01402
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    April 9, 2008
    Report Date
    May 1, 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

    THE INDEX PROCEDURE WAS AN ELECTIVE CASE. THE TARGET LESION WAS THE MID LAD. THE LESION WAS REPORTED TO BE: DE NOVO, CONCENTRIC, 15 MM LENGTH, VESSEL DIAMETER 3.0 MM, AND TYPE A. THE LESION WAS PRE-DILATED WITH A 3.0 X15 MM BALLOON AT 6 ATM FOR 60 SEC. A CYPHER 3.0 X 23 MM STENT WAS IMPLANTED AT 14 ATM FOR 30 SEC. THE STENT WAS NOT POST-DILATED. IVUS WAS DONE. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. AN ACT WAS NOT MEASURED. PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT APPROXIMATELY TWENTY-NINE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL. CORONARY ANGIOGRAPHY WAS DONE AND A PREVIOUS MYOCARDIAL INFARCTION (OMI) IN THE LEFT ANTERIOR DESCENDING (LAD) REGION, A CARDIAC ANEURYSM AND HEART FAILURE WERE OBSERVED. THE ANGIOGRAM ALSO REVEALED A HAZINESS/THROMBUS IN THE PREVIOUSLY IMPLANTED CYPHER 3.0 X 23 MM STENT. THE STENT HAD BEEN IMPLANTED IN THE MID LAD TARGET LESION. THE PATIENT WAS ASYMPTOMATIC AND THE FLOW IN THE VESSEL WAS GOOD. NO INTERVENTION WAS CONDUCTED. THE PHYSICIAN'S COMMENT REGARDING THE POSSIBLE CAUSE OF THE EVENT WAS THAT IT WAS POSSIBLY, DUE TO THE PATIENT DISCONTINUING HIS ANTIPLATELET THERAPY DUE TO RETCHING.

    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 I0805192

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L 3.0 X 15 MM BALLOON