BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1082300 · Received July 25, 2008

    Report

    Report Number
    9616099-2008-01853
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    December 7, 2007
    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. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE EMAIL RECEIVED FOR THE STUDY INDICATED THAT, AT THE 9-12TH MONTH, A FOLLOW-UP ANGIOGRAPHY SHOWED A RESTENOSIS OF THE TARGET LESION. IT WAS LEFT UNTREATED: TREATMENT BY MEDICATION ONLY. THE PT IS A MALE AT THE TIME OF THE INDEX PROCEDURE (2006). THE TARGET LESION WAS RESTENOSED DRIVER AND TAXUS STENTS. THE LESION WAS OSTIAL, IRREGULAR, CONCENTRIC, WITH NO BIFURCATION, WITH AN ANGULATION >45 AND <90 DEGREES, A MODERATE TORTUOSITY, AND A MODERATE CALCIFICATION. INDICATION FOR THE PRODUCT WAS STABLE ANGINA PECTORIS. A CYPHER STENT WAS DEPLOYED IN THE LESION AT 12 ATM. POST-DILATION WAS PERFORMED BECAUSE THE STENT WAS NOT FULLY EXPANDED (SUB-OPTIMAL RESULT), WITH A BALLOON 20 X 2.00 MM WITH DEPLOYMENT PRESSURE OF 14 ATM.

    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 I0706101

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening KARDEGIC| MEDICATIONS: PLAVIX| STATINS| BETA BLOCKERS| ACE INHIBITORS