BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1080169 · Received July 21, 2008

    Report

    Report Number
    9616099-2008-01811
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    April 17, 2008
    Report Date
    June 26, 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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDICATION FOR THE INDEX PROCEDURE WAS AN ACUTE ST-ELEVATION ANTERIOR WALL MYOCARDIAL INFARCTION (STEMI). THE PATIENT WAS FOUND TO HAVE THREE-VESSEL DISEASE. NO STAGED PROCEDURE WAS PLANNED. THE PRE AND POST-PROCEDURE CARDIAC ENZYMES WERE NOTED TO BE ELEVATED. LESION #1: THE TARGET LESION WAS THE PROXIMAL LAD. THE LESION WAS REPORTED TO BE: DE NOVO, 3.0 MM VESSEL DIAMETER, 50 MM LENGTH, A 100% STENOSIS, A CHRONIC TOTAL OCCLUSION (CTO), IRREGULAR MODERATELY CALCIFIED, AND TYPE C. THE LESION WAS PRE-DILATED WITH A 2.5 X 20 MM BALLOON AT 10 ATMS. A CYPHER SELECT PLUS 3.0 X 33 MM STENT WAS IMPLANTED AT 18 ATMS. THE STENT WAS POST-DILATED WITH A 3.0 X 10 MM BALLOON AT 15 ATMS. AN ADDITIONAL CYPHER SELECT PLUS 3.0 X 23 MM STENT WAS IMPLANTED AT 10 ATMS. LESION #2: THE TARGET LESION WAS THE MID LAD. A CYPHER SELECT PLUS 3.0 X 33 MM STENT WAS IMPLANTED. NO LESION CHARACTERISTICS OR PROCEDURAL DETAILS WERE PROVIDED FOR THIS LESION. THE PATIENT WAS DISCHARGED SIX DAYS AFTER THE PROCEDURE. AT THE ONE AND SIX-MONTH FOLLOW-UPS, THE PATIENT WAS ASYMPTOMATIC AND WAS CONTINUING HER MEDICAL REGIMEN. PLEASE NOTE THAT DEVICE (LOT# 13307567) IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER IT IS SIMILAR TOT HE 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 STUDY INDICATED THAT APPROXIMATELY FOUR MONTHS AFTER THE INDEX PROCEDURE, A STAGED PROCEDURE/RE-PCI WAS DONE. THE PT WAS FOUND TO HAVE AN 80% FOCAL IN-STENT RESTENOSIS AND A PROXIMAL PERI-STENT RESTENOSIS PF, THE PREVIOUSLY IMPLANTED CYPHER SELECT PLUS 3.0 X 33 MM STENT. THE STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) TARGET LESION. THE RESTENOSIS WAS TREATED BY IMPLANTATION OF AN ADDITIONAL CYPHER SELECT PLUS 3.0 X 13 MM STENT IN THE LEFT MAIN CORONARY ARTERY IN OVERLAPPING FASHION WITH THE 3.0 X 33 MM STENT. THE RESIDUAL STENOSIS WAS 5%.

    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 13307567

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 3.0 X 10 MM BALLOON| 2.5 X 20 MM BALLOON