BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1040301 · Received May 7, 2008

    Report

    Report Number
    9616099-2008-01252
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    November 20, 2007
    Report Date
    April 16, 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 ELECTIVE CASE. THE TARGET LESION WAS AT THE PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA). THE VESSEL WAS A DE-NOVO AND A TOTAL OCCLUSION. LESION CLASSIFICATION WAS TYPE C. THE LESION LENGTH WAS APPROX 60 MM AND THE VESSEL DIAMETER WAS 2.5-3.0MM. THE INFO OF PREDILATATION IS UNK. THE FIRST 2.5 X 28 MM CYPHER STENT WAS IMPLANTED. A SECOND 3.0 X 33 MM CYPHER STENT WAS IMPLANTED PROXIMAL TO THE 1ST CYPHER STENT AND OVERLAPPING IT. THE INFLATION PRESSURE AND TIME WERE UNK. THE INFO OF PRE-DILATATION, IVUS, THE RESIDUAL % OF STENOSIS, TIMI FLOW BEFORE THE PROCEDURE, AND ACT ARE UNK. THIS IS ONE OF TWO PRODS BEING REPORTED FOR THE SAME EVENT. PLEASE REFERENCE MFG REPORTS #: PLEASE NOTE; DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PROD. ANY ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    NOTIFICATION WAS REC'D FROM THE AFFILIATE INDICATING THAT TWENTY-SEVEN MOS POST INDEX PROCEDURE, THE PT CAME TO THE HOSPITAL FOR F/U. THE PT WAS NOT SHOWING ANY SYMPTOMS. A CORONARY ANGIOGRAM WAS CONDUCTED AND THROMBUS WAS OBSERVED INSIDE BOTH CYPHER STENTS. RESTENOSIS WAS OBSERVED AT THE OVERLAPPING PORTION. TWENTY-THREE DAYS LATER, THE THROMBUS WAS TREATED. TO TREAT THE THROMBUS, UROKINASE WAS ADMINISTERED (480,000U) AND PLAIN OLD BALLOON ANGIOPLASTY WAS CONDUCTED WITH A 2.5 X 20 MM BALLOON. INFLATION PRESSURE AND TIME WAS UNK. THEN A TSUNAMI BARE METAL STENT WAS IMPLANTED AT THE OVERLAPPING PORTION. THE PT RECOVERED AND WAS DISCHARGED FOUR DAYS LATER. PHYSICIAN'S COMMENT: THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS DUE TO STENT RESTENOSIS.

    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 58 YR Hospitalization| L| R 3.0X33 MM CYPHER STENT