BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1161173 · Received September 15, 2008

    Report

    Report Number
    9616099-2008-02245
    Event Type
    Death
    Date Received
    September 15, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 26, 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 REPORTED #9616099-2008-002244. 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 IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) AND IT WAS DE-NOVO, ECCENTRIC, BIFURCATED AND A THROMBOTIC TOTAL OCCLUSION LESION. AHA/ACC CLASSIFICATION OF THE VESSEL WAS TYPE C. THE LESION LENGTH WAS 44 MM AND VESSEL DIAMETER WAS 2.5 MM. THE PROCEDURE WAS AN EMERGENT CASE DUE TO AMI. PRE-DILATATION WAS CONDUCTED WITH A 2.0 X 15 MM BALLOON AT 8 ATM FOR 30 SECONDS. A 2.5 X 28 MM CYPHER WAS IMPLANTED AT 18 ATM FOR 30 SECONDS, A 2.75 X 18 MM CYPHER WAS IMPLANTED AT 18 ATM FOR 30 SECONDS PROXIMAL TO THE 1ST CYPHER OVERLAPPING IT. POST-DILATATION WAS CONDUCTED WITH A 2.5 X 15 MM BALLOON AT 20 ATM. THE DILATATION TIME WAS UNKNOWN, BUT POST-DILATATION WAS CONDUCTED 4 TIMES. IVUS WAS CONDUCTED. THE RESIDUAL % OF STENOSIS WAS 0%. TIMI FLOW BEFORE THE PROCEDURE WAS 0 AND 3 AFTER THE PROCEDURE. ACT WAS NOT MEASURED. NINE DAYS AFTER THE PROCEDURE, THE PT COMPLAINED OF CHEST PAIN AND HIS BLOOD PRESSURE DECREASED. HE DEVELOPED HEART FAILURE AND CARDIOGENIC SHOCK. CORONARY ANGIOGRAPHY WAS CONDUCTED AND THROMBUS WAS OBSERVED IN BOTH OF THE IMPLANTED CYPHER STENTS. TO TREAT THE THROMBUS, ASPIRATION AND BALLOON ANGIOPLASTY WERE CONDUCTED. INFLATION PRESSURE AND TIME WAS UNKNOWN. AFTER THE TREATMENT FOR THE THROMBUS, VESSEL FLOW IMPROVED TEMPORARILY, BUT THE PT PASSED AWAY IN THE HOSP. POSTMORTEM WAS NOT PERFORMED. PHYSICIAN INDICATED THAT THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE THE CYPHER STENTS WERE IMPLANTED IN A THROMBOTIC TOTAL OCCLUSION LESION. THE CAUSE OF THE DEATH WAS HEART FAILURE.

    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 13411057

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| H| R ASPIRIN| CLOPIDOGREL