BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1082253 · Received July 24, 2008

    Report

    Report Number
    9616099-2008-01848
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    January 30, 2008
    Report Date
    June 27, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDEX PROCEDURE WAS AN ELECTIVE CASE. THE TARGET LESION WAS THE POSTERO-LATERAL BRANCH. THE LESION WAS REPORTED TO BE: AN IN-STENT RESTENOSIS (ISR) OF A PREVIOUSLY IMPLANTED BARE METAL/PIXEL STENT, BIFURCATED, 20MM LENGTH, VESSEL DIAMETER 2.5 MM, AND TYPE B2. THE LESION WAS PRE-DILATED WITH A 2.5 X 15 MM BALLOON AT 15 ATM/DURATION UNKNOWN. A CYPHER 2.5 X 23MM STENT WAS IMPLANTED AT 16 ATM/DURATION UNKNOWN. THE STENT WAS POST-DILATED USING A KISSING BALLOON TECHNIQUE (KBT) WITH A 2.5 X 15 MM BALLOON AT 15 ATM/DURATION UNKNOWN. IVUS WAS NOT DONE. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. AN ACT WAS NOT MEASURED. PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR EVAL AND TESTING. MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT APPROXIMATELY TWENTY-FOUR AND ONE-HALF MONTHS AFTER THE INDEX PROCEDURE AFTER SURGERY FOR AN ABDOMINAL INCISIONAL HERNIA, THE PT COMPLAINED OF CHEST PAIN. CORONARY ANGIOGRAPHY WAS DONE AND THROMBUS WAS OBSERVED INSIDE THE PREVIOUSLY IMPLANTED CYPHER 2.5 X 23 MM STENT IN THE POSTERO-LATERAL BRANCH. THE VERY LATE THROMBOSIS (VLT) WAS TREATED BY ASPIRATION OF THE THROMBUS AND BALLOON ANGIOPLASTY USING A HIRYU 2.75 X 12MM BALLOON AT 20 ATM. THE PT WAS DISCHARGED FROM THE HOSPITAL TWO WEEKS AFTER THE RE-INTERVENTION. THE PHYSICIAN'S COMMENT REGRADING THE PROBABLE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE THE ANTIPLATELET THERAPY WAS DISCONTINUED SIX DAYS BEFORE THE SURGERY.

    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 I1005015

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R 2.5 X 15MM BALLOON