BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1040433 · Received May 9, 2008

    Report

    Report Number
    9616099-2008-01270
    Event Type
    Death
    Date Received
    May 9, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 15, 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

    THE TARGET LESION WAS THE LEFT MAIN TO THE PROXIMAL LAD AND THE PROXIMAL CIRCUMFLEX. FOR THE LEFT MAIN AN PROXIMAL LAD, THE VESSEL WAS DE-NOVO, BIFURCATED, CALCIFIED AND OSTIAL. AHA/ACC CLASSIFICATION OF THE VESSEL WAS TYPE C. THE LESION LENGTH WAS 26.3MM AND VESSEL DIAMETER WAS 4.1MM. FOR THE PROXIMAL CIRCUMFLEX, THE VESSEL WAS DE-NOVO, BIFURCATED AND CALCIFIED. AHA/ACC CLASSIFICATION OF THE VESSEL WAS TYPE B2. THE LESION LENGTH WAS 12MM AND VESSEL DIAMETER WAS 3.2MM. THE PROCEDURE WAS AN ELECTIVE CASE. FOR THE PROXIMAL LAD, PRE-DILATATION WAS CONDUCTED. A 3.5 X 18MM CYPHER WAS IMPLANTED AT 20 ATM FOR 20SECONDS. POST-DILATATION WAS CONDUCTED WITH A 3.5 X 18MM BALLOON AT 10ATM FOR 20SECONDS. POST-DILATATION WAS CONDUCTED WITH A 3.5X18MM BALLOON AT 10ATM FOR 20SECONDS. IVUS WAS CONDUCTED. THE RESIDUAL % OF STENOSIS WAS 0%. TIMI FLOW WAS 3 BEFORE THE PROCEDURE AND 3 AFTER THE PROCEDURE. FOR THE PROXIMAL CIRCUMFLEX, PRE-DILATATION WAS CONDUCTED WITH A 2.5 X 15MM BALLOON AT 14 ATM FOR 20 SECONDS. A 3.0 X 13MM CYPHER WAS IMPLANTED AT 14 ATM FOR 20 SECONDS. 1ST AND 2ND CYPHER WERE IMPLANTED BY T-STENTING. POST-DILATATION WAS CONDUCTED WITH A 2.75 X 15MM BALLOON AT 18 ATM FOR 10 SECONDS. IVUS WAS CONDUCTED. THE RESIDUAL % OF STENOSIS WAS 0%. TIMI FLOW BEFORE THE PROCEDURE WAS 3 AND 3 AFTER THE PROCEDURE. ACT WAS NOT MEASURED. TWO WEEKS AFTER THE PROCEDURE, THE PATIENT DEVELOPED CARDIOPULMONARY ARREST AND HE WAS BROUGHT TO THE HOSPITAL AS AN EMERGENCY. CORONARY ANGIOGRAPHY WAS CONDUCTED AND THROMBUS WAS OBSERVED IN THE 1ST AND 2ND CYPHER STENTS. TO TREAT THE THROMBUS, BALLOON ANGIOPLASTY WAS CONDUCTED. THE BLOOD FLOW WAS RECOVERED, BUT THE PATIENT PASSED AWAY. POSTMORTEM WAS NOT PERFORMED. PHYSICIAN INDICATED THAT THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE CLOPIDOGREL SULFATE DIDN'T WORK WELL AND THE PATIENT MIGHT NOT HAVE TAKEN ANTI-PLATELET MEDICINE CORRECTLY. 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 #9616099-2008-01269. 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

    TWO WEEKS AFTER RECEIVING TWO CYPHER STENTS, THE PATIENT HAD THROMBOSIS AND CARDIOPULMONARY ARREST. THE PATIENT SUBSEQUENTLY DIED.

    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 13324892

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| R ASPIRIN| CLOPIDOGREL