BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021037 · Received March 26, 2008

    Report

    Report Number
    9616099-2008-00750
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    September 5, 2005
    Report Date
    November 13, 2005
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE SIX-MONTH FOLLOW UP, THE PATIENT HAD A POSITIVE STRESS TEST AND CORONARY ANGIOGRAM REVEALED A 100% STENOSIS OF THE PREVIOUSLY STENTED MAIN BRANCH WITH A TIMI FLOW OF I. IT WAS TREATED BY STENTING. AT THE TWELVE-MONTH FOLLOW UP, THE PATIENT HAD ANOTHER EPISODE OF RESTENOSIS, WHICH WAS TREATED BY STENTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE CLINICAL STUDY REGISTRY INDICATED THAT THE PATIENT HAD TWO RESTENOSIS EPISODES; THE FIRST WITHIN SIX MONTHS AFTER THE INDEX PROCEDURE, AND THE SECOND EPISODE WITHIN TWELVE MONTHS AFTER RECEIVING A CYPHER STENT. AT THE INDEX PROCEDURE, A 2.5 X 23MM CYPHER STENT WAS IMPLANTED AT 12 ATMS THE MAIN INTERMEDIATE BRANCH (INTERMEDIATE 1) TO TREAT A LESION DESCRIBED AS DE NOVO WITH VISUAL DIMENSIONS OF 2.5 X 10MM, OSTIAL, ECCENTRIC AND DIFFUSE WITH MODERATE TO HEAVY CALCIFICATION, 45 TO 95 DEGREE ANGULATION AND 99% STENOSIS WITH A TIMI FLOW OF 1. THE VESSEL WAS PREDILATED WITH AN UNKNOWN 2.5 X 13MM BALLOON AT 12 ATMS. POST DILATATION WAS NOT CONDUCTED AND KISSING BALLOON WAS NOT CONDUCTED. FINAL TIMI FLOW WAS III. THE SIDE BRANCH, (THE INTERMEDIATE 2) WAS DESCRIBED AS 2.25 X 5MM, DE NOVO, OSTIAL, ECCENTRIC AND DIFFUSE WITH MODERATE TO HEAVY CALCIFICATION WITH A 45 DEGREE TO 90 DEGREE ANGULATION AND 80% STENOSIS. IT WAS TREATED BY BALLOON ANGIOPLASTY AT 12 ATMS WITH AN UNKNOWN 2.0 X 20MM BALLOON. NEITHER POST DILATATION NOR KISSING BALLOON WAS CONDUCTED. A 10 PERCENT RESIDUAL STENOSIS REMAINED WITH A TIMI FLOW OF III. A DISSECTION OF THE MAIN BRANCH OCCURRED AND WAS TREATED WITH AN ADDITIONAL DRIVER STENT.

    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 I1105091

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention