BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1082252 · Received July 24, 2008

    Report

    Report Number
    9616099-2008-01844
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    October 4, 2006
    Report Date
    June 30, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THE STERILE LOT NUMBER FOR THE 3.0MM X 23MM CYPHER STENT IS UNKNOWN THEREFORE A DEVICE HISTORY REVIEW REPORT COULD NOT BE CONDUCTED. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING A CORONARY STENT. REVIEW OF THE AVAILABLE INFO SUGGESTS THAT PT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE STUDY INDICATED THAT A PT EXPERIENCED RESTENOSIS AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT'S HISTORY IS SIGNIFICANT FOR HYPERTENSION, HYPERLIPIDEMIA, PERIPHERAL VASCULAR DISEASE, DIABETES AND REMOTE HISTORY OF SMOKING. THE PATIENT'S MEDICAL HISTORY PUTS THEM AT INCREASED RISK OF A MACE. THE INDICATION FOR THE PROCEDURE IS UNKNOWN. THE TARGET VESSEL WAS THE MID-LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS TREATED WITH THE DEPLOYMENT OF A 3.0 MM X 23 MM CYPHER STENT. THE PROCEDURAL DETAILS SURROUNDING THE EVENT ARE UNKNOWN. APPROXIMATELY SIX MONTHS LATER, REPEAT ANGIOGRAPHY WAS PERFORMED ON THE PT FOR SILENT ISCHEMIA. RESTENOSIS WAS OBSERVED IN THE PREVIOUSLY IMPLANTED CYPHER STENT. THE VESSEL WAS DESCRIBED AS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. THE LESION WAS PRE-DILATED WITH A 2.5MM X 6MM BALLOON AT 10 ATMS FOLLOWED BY THE DEPLOYMENT OF A 3.0MM X 13MM CYPHER SELECT STENT AT 16 ATMS. IT IS UNKNOWN IF THE STENT WAS POST-DILATED. THE PT WAS HOSPITALIZED APPROXIMATELY SEVEN MONTHS LATER WITH SILENT ISCHEMIA. REPEAT ANGIOGRAPHY REVEALED THE STENT TO BE PATENT WITH NO RESTENOSIS.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention PLAVIX| KARDEGIC| MEDICATIONS: STATINS