BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021274 · Received March 25, 2008

    Report

    Report Number
    9616099-2008-00775
    Event Type
    Death
    Date Received
    March 25, 2008
    Date of Event
    February 11, 2008
    Report Date
    March 7, 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

    THIS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. THIS IS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PT REPORTED UNDER MFG NUMBERS 9616099-2008-00774 AND 9616099-2008-00775. ADD'L INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM A FOREIGN COUNTRY, INDICATED THE PT HAD A THROMBOTIC EVENT 16 MOS AFTER RECEIVING TWO CYPHER STENTS. HE SUBSEQUENTLY DIED OF MULTI ORGAN FAILURE AFTER RESPIRATORY COMPLICATIONS. THE MAIN INDICATION FOR THE INDEX PROCEDURE WAS ACUTE CORONARY SYNDROME. AFTER PREDILATATION OF THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH AN UNK 3.0 X 20MM BALLOON AT 8ATMS, A 3.0 X 20MM CYPHER WAS IMPLANTED AT 18 ATMS FOR 29 SECONDS. THE VESSEL WAS DESCRIBED AS 3.0 X 16MM LONG, OSTIAL AND DE NOVO WITH A TYPE B2 CLASSIFICATION. A KISSING BALLOON POST DILATATION WAS CONDUCTED WITH A 3.5 X 20 MM UNK BALLOON; PRESSURE UNK. RESIDUAL STENOSIS WAS ZERO. A SECOND LESION IN THE FIRST DIAGONAL WAS TREATED BY IMPLANTATION OF 2.5 X 23MM CYPHER STENT AND A 2.5 X 20MM TSUNAMI STENT OVERLAPPING ONE ANOTHER. KISSING POST DILATATION WAS CONDUCTED WITH A 2.5 X 20MM UNK BALLOON FOR A RESIDUAL STENOSIS OF ZERO. FIFTEEN MOS LATER, THE PT WAS HOSPITALIZED FOR BRAIN INFARCTION. DURING THIS TIME, ASPIRIN AND CLOPIDOGREL WERE ON HOLD DUE TO ANTICOAGULANT THERAPY SIDE EFFECT FOR THE BRAIN INFARCT. PT WAS TRANSFERRED TO ANOTHER FACILITY AS THE PT'S RESPIRATORY STATUS WORSENED. THE PT WAS IN SHOCK ON ARRIVAL AND WAS PLACED ON INTRA AORTIC BALLOON PUMP. CORONARY ANGIOGRAM REVEALED A THROMBUS FROM THE LEFT MAIN TRUNK TO INSIDE THE IMPLANTED CYPHER IN PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE THROMBUS WAS ASPIRATED WITH GOOD RESULTS AND THE INTRA AORTIC BALLOON PUMP WAS DISCONTINUED. HOWEVER, THE PT'S RESPIRATORY CONDITION REMAINED UNSTABLE AND THE PT WAS DIAGNOSED WITH ACUTE RESPIRATORY DISTRESS SYNDROME. AFTER RECEIVING A TRACHEOTOMY, THE PT CONTINUED TO DETERIORATE; HEART FAILURE WORSENED AND PT DEVELOPED PLEURAL EFFUSION. THE PT EVENTUALLY DIED OF MULTI ORGAN FAILURE. ACCORDING TO THE PHYSICIAN, THE THROMBOTIC EVENT OCCURRED BECAUSE ASPIRIN AND CLOPIDOGREL WERE WITHHELD DURING THE BRAIN INFARCTION.

    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 I0606030

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death ASPIRIN| CLOPIDOGREL| TISSUE PLASMINOGEN ACTIVATOR (TPA)