BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1201547 · Received October 17, 2008

    Report

    Report Number
    9616099-2008-02473
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 2, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. THIS PRODUCT REMAINS IMPLANTED IN THE PATIENT AND WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFO WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THE PATIENT SUFFERED A CORONARY STENT THROMBOSIS. THE INITIAL PROCEDURE WAS ELECTIVE . THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS DE NOVO TYPE B2, ECCENTRIC AND BIFURCATED. THE VESSEL LENGTH WAS APPROXIMATELY 20MM AND THE VESSEL DIAMETER WAS 2.5MM. PRE-DILATION WAS CONDUCTED WITH A BALLOON AT 8ATM FOR 30 SECONDS. THEN CYPHER (2.5/23MM) WAS IMPLANTED AT 8ATM FOR 30 SECONDS. POST-DILATION WAS NOT CONDUCTED. IVUS WAS CONDUCTED. THE RESIDUAL % OF STENOSIS WAS 25%. TIMI FLOW 3 WAS PRESENT BEFORE AND AFTER THE PROCEDURE. ACT WAS NOT MEASURED. THIRTY-FOUR MONTHS POST STENT IMPLANT THE PATIENT COMPLAINED OF CHEST PAIN. AN ELECTROCARDIOGRAM ABNORMALITY WAS CONFIRMED. CORONARY ANGIOGRAM (CAG) WAS CONDUCTED AND THROMBUS WAS OBSERVED INSIDE THE CYPHER IMPLANTED THE PREVIOUSLY IMPLANTED STENT. TO TREAT THE THROMBUS ASPIRATION AND POBA WITH A BALLOON (VOYAGER: 2.5/20MM) WAS CONDUCTED AT 12 ATM. INFLATION TIME WAS UNKNOWN. THEN BEAR METAL STENT (BMS) (VISION: 3.5/15MM) WAS IMPLANTED INSIDE THE IMPLANTED CYPHER AT 12ATM. INFLATION TIME WAS UNKNOWN. PHYSICIAN'S COMMENT: THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS THAT THE ANTI-PLATELET THERAPY WAS STOPPED SIX DAYS PRIOR TO THE ONSET OF THE CHEST PAIN BECAUSE A COLONOSCOPY PROCEDURE WAS CONDUCTED.

    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 I0805152

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR ON BECAUSE THE COLONOSCOPY WAS CONDUCTED.| BALLOON CATHETER (2.0/23MM)| CYPHER IMPLANT)| ASPIRIN AND TICLOPIDINE HYDROCHLORIDE WAS STOPPED| HEPARIN UNK 8| ASPIRIN 200MG/DAY: UNK (PRIOR TO THE CYPHER| TICLOPIDINE HYDROCHLORIDE 200/DAY: UNK (PRIOR TO| IMPLANT)