BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 743438 · Received July 31, 2006

    Report

    Report Number
    9616099-2006-00836
    Event Type
    Injury
    Date Received
    July 31, 2006
    Date of Event
    July 3, 2006
    Report Date
    July 31, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT DEVICE (CJS23300, LOT # I0406017) IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT CXS23300. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT FROM THE AFFILIATE INDICATED THAT DURING A PCI PROCEDURE TO IMPLANT A CYPHER 3.0/23 MM STENT IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY THE FIRST DIAGONAL CORONARY ARTERY WAS OCCLUDED OR "JAILED". THE MID LAD WAS REPORTED TO BE: NOT CALCIFIED OR TORTUOUS, A 90% STENOSIS AND A BIFURCATION LESION. THE APPROACH FOR THE PROCEDURE WAS FEMORAL. IVUS WAS DONE AND THE LESION WAS THEN PRE-DILATED WITH A SCIPIO 3.0/23 MM BALLOON AT 10 ATM FOR 30 SEC. A CYPHER 3.0/23 MM STENT WAS IMPLANTED BUT THE SDS BALLOON RUPTURED AT 10 ATM. THE SDS WAS REMOVED AND THE STENT WAS POST-DILATED TWICE USING A SEMI-COMPLIANT SCIPIO BALLOON TWICE AT 14 ATM FOR 30 SEC. THE OCCLUSION/JAILING OF THE 1ST DIAGNOAL WAS NOTED AFTER POST-DILATING THE STENT. IVUS WAS DONE AND CONFIRMED THE CYPHER STENT WAS FULLY DILATED. DUE TO THE OCCLUSION/JAILING OF THE 1ST DIAGNAL, A SPRINTER 2.25/15 MM BALLOON WAS INFLATED AT THE STENT STRUT/OSTIUM OF THE VESSEL AT 12 ATM FOR 30 SEC. A FINAL IVUS WAS DONE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS DE MEXICO NA I0406017

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention