BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1032314 · Received April 21, 2008

    Report

    Report Number
    9616099-2008-01058
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    September 5, 2007
    Report Date
    March 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. THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 9616099-2008-01059. 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 PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE VESSEL WAS A DE-NOVO, CONCENTRIC AND BIFURCATED LESION. THE PROCEDURE WAS AN ELECTIVE CASE. PRE-DILATATION WAS CONDUCTED WITH A 2.5 X 15 MM BALLOON AT 14 ATM FOR 30 SECONDS. A 2.5 X 23 MM CYPHER STENT WAS IMPLANTED AT 16 ATM FOR 30 SECONDS. A 3.0 X 18MM CYPHER STENT WAS IMPLANTED AT 18 ATM FOR 30 SECONDS PROXIMAL TO THE 1ST CYPHER OVERLAPPING IT. POST-DILATATION WAS CONDUCTED WITH A 3.0 X 20MM BALLOON AT 20ATM FOR 30 SECONDS. IVUS WAS CONDUCTED. THE RESIDUAL % OF STENOSIS WAS 0%. TIMI FLOW WAS 1 BEFORE THE PROCEDURE AND 3 AFTER THE PROCEDURE. ACT WAS NOT MEASURED. THREE MONTHS LATER, THE PT COMPLAINED OF CHEST PAIN AND CAME TO THE HOSP. ABNORMAL ECG WAS OBSERVED. CORONARY ANGIOGRAPHY WAS CONDUCTED AND THROMBUS WAS OBSERVED IN THE CYPHER STENTS. TO TREAT THE THROMBUS, ASPIRATION AND BALLOON ANGIOPLASTY WAS CONDUCTED WITH A 3.25 X 8 MM BALLOON. IVUS WAS CONDUCTED AND LATE INCOMPLETE STENT APPOSITION WAS OBSERVED IN THE CYPHER STENTS. A WEEK LATER, THE PT RECOVERED AND WAS DISCHARGED FROM THE HOSP. PHYSICIAN INDICATED THAT THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS DUE TO THE LATE INCOMPLETE STENT APPOSITION.

    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 13204561

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R TICLOPIDINE HYDROCHLORIDE| ASPIRIN