BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1833809 · Received September 14, 2010

    Report

    Report Number
    1823260-2010-05417
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    September 3, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 2.1 INR ON THE COAGUCHEK XS SYSTEM AND 5.7 INR ON A COMPARISON LAB. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    THE TARGET LESION WAS IN THE PROXIMAL RCA. THE LESION WAS AN ISR OF A PREVIOUSLY IMPLANTED BMS (BRAND AND NUMBER OF UNITS WERE UNSPECIFIED), OSTIAL AND CALCIFIED LESION. AHA/ACC CLASSIFICATION OF THE VESSEL WAS TYPE C. THE LESION LENGTH WAS APPROXIMATELY 70MM AND THE VESSEL DIAMETER WAS APPROXIMATELY 2.5MM. IT WAS AN ELECTIVE CASE. IT IS UNKNOWN IF PRE-DILATION WAS CONDUCTED. THE 1ST CYPHER BX (2.5/28MM) WAS IMPLANTED AT 15ATM (INFLATION TIME UNKNOWN) AT THE DISTAL PORTION OF THE TARGET LESION. THEN, THE 2ND CYPHER BX (2.5/28MM) WAS IMPLANTED AT 15ATM (INFLATION TIME UNKNOWN) PROXIMAL TO THE 1ST CYPHER BX. FINALLY THE 3RD CYPHER BX (2.5/23MM) WAS IMPLANTED AT 30ATM (INFLATION TIME UNKNOWN) PROXIMAL TO THE 2ND CYPHER BX. IT IS UNKNOWN IF POST-DILATION WAS CONDUCTED. THE RESIDUAL % OF STENOSIS WAS UNKNOWN. TIMI FLOWS BEFORE AND AFTER THE PROCEDURE WERE UNKNOWN. IVUS WAS NOT CONDUCTED. IT IS UNKNOWN IF ACT WAS MEASURED. FIVE DAYS POST PROCEDURE, THE PATIENT DEVELOPED UNSTABLE ANGINA. ANGIOGRAPHY WAS CONDUCTED AND THROMBUS WAS OBSERVED INSIDE OF ALL THREE IMPLANTED CYPHER STENTS IN THE RCA. WHEN IVUS WAS CONDUCTED, A STENT FRACTURE WAS OBSERVED IN THE 2.5 X 23MM CYPHER STENT IMPLANTED IN THE PROXIMAL PORTION OF THE LESION. TO TREAT THE THROMBUS, ASPIRATION AND BALLOON ANGIOPLASTY WERE CONDUCTED. TREATMENT FOR THE STENT FRACTURE WAS UNKNOWN. PHYSICIAN'S COMMENT: THE POSSIBLE CAUSES OF THE THROMBOTIC EVENT IS THAT THE LESION WAS AN IN-STENT RESTENOSIS AND THAT THE STENT IMPLANTED IN THE PROXIMAL PORTION OF THE RCA MAY HAVE BEEN UNDER-DILATED BECAUSE OF THE HEAVILY CALCIFIED LESION, AND THE EFFECT OF THE STENT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20180332

    Patients

    Seq Age Sex Outcome Treatment
    1 075 YR