BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1001494 · Received February 19, 2008

    Report

    Report Number
    9616099-2008-00378
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 25, 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

    THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE TARGET LESION WAS THE MID RIGHT CORONARY ARTERY (RCA). THE PROCEDURE WAS AN EMERGENT CASE DUE TO WORSENING CONGESTIVE HEART FAILURE. PRE-DILATION WAS CONDUCTED WITH A 2.5 X 15MM BALLOON AT 12ATM FOR 120SECONDS. A 2.5 X 16MM TAXUS STENT WAS IMPLANTED AT 12ATM FOR 60 SECONDS AT THE TARGET LESION. THEN, A 2.5 X 23MM CYPHER STENT WAS IMPLANTED AT 20ATM FOR 60 SECONDS AT THE PROXIMAL END OF THE TAXUS STENT LEAVING A GAP (AROUND 2 APROX 3 STRUTS LENGTH) BETWEEN THE TAXUS STENT AND THE CYPHER STENT. POST-DILATION WAS NOT CONDUCTED. TIMI FLOW BEFORE THE PROCEDURE WAS 2 AND 3 AFTER THE PROCEDURE. IVUS WAS CONDUCTED. THE RESIDUAL % OF STENOSIS WAS 36%. ACT WAS CONDUCTED (198). THE FOLLOWING DAY AFTER THE PROCEDURE, THE PT COMPLAINED OF CHEST PAIN DURING THE HOSPITALIZATION. CORONARY ANGIOGRAPHY WAS CONDUCTED AND THROMBUS WAS OBSERVED AT THE PROXIMAL END INSIDE OF THE IMPLANTED CYPHER STENT. TO TREAT THE THROMBUS, ASPIRATION (THROMBUSTER) WAS CONDUCTED AND THROMBOLYTIC AGENT (UROKINASE: 240,000U) WAS ADMINISTRATED. TIMI FLOW BECAME 3. THEN, A DRIVER BARE METAL STENT WAS IMPLANTED AT THE GAP BETWEEN THE TAXUS STENT AND THE CYPER STENT. BALLOON ANGIOPLASTY WAS CONDUCTED. HEART FAILURE OF THE PT WORSENED, AND SO THE PT IS STILL HOSPITALIZED.

    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 13317390

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention CLOPIDOGREL| ASPIRIN| HEPARIN