BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1063213 · Received June 17, 2008

    Report

    Report Number
    9616099-2008-01533
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 18, 2008
    Report Date
    May 27, 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

    THE PROCEDURE WAS AN EMERGENT CASE DUE TO AN ACUTE MYOCARDIAL INFARCTION. THE TARGET LESION WAS THE MID RCA. THE VESSEL WAS A DE-NOVO, ECCENTRIC AND A TOTALLY OCCLUDED LESION. LESION CLASSIFICATION WAS TYPE B1. THE LESION LENGTH WAS 10MM AND VESSEL DIAMETER WAS 2.5MM. PRE-DILATATION WAS CONDUCTED WITH A 2.5X14MM BALLOON AT 8ATM FOR 60 SECONDS. A 2.5X18MM CYPHER STENT WAS DEPLOYED AT 14ATM FOR 60 SECONDS. POST-DILATATION WAS NOT CONDUCTED. IVUS WAS NOT CONDUCTED. THERE WAS AN UNTREATED LESION AT THE PROXIMAL PORTION OF THE IMPLANTED CYPHER, BUT IT WAS NOT TREATED BECAUSE THE LESION WAS 25-50% STENOSIS. THE RESIDUAL % OF STENOSIS WAS 0%. TIMI FLOW PRE AND POST PROCEDURE WAS 0 AND 3. ACTIVATED CLOTTING TIME WAS MEASURED. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. ANY ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A REPORT WAS REC'D FROM THE AFFILIATE INDICATING THAT A FEW HOURS AFTER THE PERCUTANEOUS INTERVENTION, THE PT COMPLAINED OF CHEST PAIN AND HAD VENTRICULAR FIBRILLATION. A CORONARY ANGIOGRAM WAS CONDUCTED AND THROMBUS WAS OBSERVED INSIDE OF THE IMPLANTED CYPHER. TO TREAT THE THROMBUS, ONLY INTRA AORTIC BALLOON PUMP WAS INSERTED BECAUSE SUFFICIENT BLOOD FLOW WAS CONFIRMED. AS OF 2008 THE PT REMAINS HOSPITALIZED AND HER CONDITION IS STABLE. PHYSICIAN'S COMMENT: THE CAUSE OF THROMBOTIC EVENT MAY BE BECAUSE THE ANTI-PLATELET THERAPY WAS NOT EFFECTIVE, VOMITING DURING THE PCI.

    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 13370536

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R 2.5X14MM BALLOON