BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1015047 · Received March 17, 2008

    Report

    Report Number
    9616099-2008-00647
    Event Type
    Injury
    Date Received
    March 17, 2008
    Date of Event
    February 17, 2008
    Report Date
    February 20, 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 # 9616099-2008-00646. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE TARGET LESION WAS THE LEFT MAIN. THE VESSEL WAS A DE-NOVO AND BIFURCATED LESION. AHA/ACC CLASSIFICATION OF THE VESSEL WAS TYPE B2. THE LESION LENGTH WAS 18MM AND VESSEL DIAMETER WAS 4.0MM. THE PROCEDURE WAS AN EMERGENT CASE DUE TO UNSTABLE ANGINA. PRE-DILATATION WAS NOT CONDUCTED. A 3.5 X 18MM CYPHER STENT WAS IMPLANTED AT 16ATM FOR 5 SECONDS. ANOTHER 3.5 X 18MM CYPHER STENT WAS IMPLANTED AT 12ATM FOR 5 SECONDS BY Y-STENTING. POST-DILATATION WAS CONDUCTED WITH A 3.0 X 15MM BALLOON AT 14ATM FOR 5 SECONDS. KBT WAS CONDUCTED. IVUS WAS CONDUCTED. THE RESIDUAL % OF STENOSIS WAS 0%. TIMI FLOW BEFORE THE PROCEDURE WAS UNKNOWN AND 3 AFTER THE PROCEDURE. ACT WAS NOT MEASURED. AT THE THREE MONTH FOLLOW UP IN 2005, THERE WERE NO ISSUES. IN 2008, THE PT COMPLAINED OF CHEST PAIN AND HE WAS BROUGHT TO THE HOSPITAL AS AN EMERGENCY. ST ELEVATION WAS OBSERVED. CORONARY ANGIOGRAPHY WAS CONDUCTED AND THROMBUS WAS OBSERVED IN THE IMPLANTED CYPHER STENTS. TO TREAT THE THROMBUS, IABP WAS CONDUCTED. PHYSICIAN INDICATED THAT THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE THE STENTS WERE UNDER-DILATED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R ASPIRIN