BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 726258 · Received June 13, 2006

    Report

    Report Number
    9616099-2006-00632
    Event Type
    Injury
    Date Received
    June 13, 2006
    Date of Event
    May 10, 2006
    Report Date
    June 8, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT DEVICE (CJS23300, LOT# I0306057) IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER IT IS SIMILAR TO THE UNITED STATES PRODUCT CXS23300.

    Description of Event or Problem · 1

    THE REPORT FROM THE AFFILIATE INDICATED THAT ONE (1) HOUR AFTER THE INDEX PROCEDURE THE PT COMPLAINED OF CHEST PAIN. REPEAT CORONARY ANGIOGRAPHY WAS DONE AND THROMBUS WAS OBSERVED IN THE DISTAL TO THE IMPLANTED CYPHER STENT. THE THROMBOSIS WAS TREATED BY ASPIRATION AND PTCA USING A QUANTUM MAVERICK 3.0/20 MM BALLOON AT 23 ATM WITH AN UNK INFLATION TIME. THE PT WAS PUT ON AN INTRA AORTIC BALLOON PUMP (IABP). THE PT'S CARDIAC FUNCTION WAS REPORTED TO BE IMPROVING AT THE TIME OF THE REPORT. THE PHYSICIAN'S COMMENT REGARDING THE THROMBOTIC EVENT WAS THAT THE PT WAS PRONE TO DEVELOPING THROMBUS (DIATHESIS). THE INDEX PROCEDURE WAS AN EMERGENT CASE DUE TO ACUTE CORONARY SYNDROME (ACS). THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE LESION WAS REPORTED TO BE: DE NOVO, ECCENTRIC, 14MM IN LENGTH, VESSEL DIAMETER 2.5 MM, A BIFURCATION LESION, AND TYPE B2. THE LESION WAS PREDILATED WITH A 2.5/15 MM BALLOON AT 6 ATM FOR 20 SEC. A CYPHER 3.0/23 MM STENT WAS IMPLANTED AT 16 ATM FOR 20 SEC. A CYPHER 3.0/23 MM STENT WAS IMPLANTED AT 16 ATM FOR 20 SEC USING THE KISSING BALLOON TECHNIQUE (THERE WAS NO INFO REGARDING THE OTHER BALLOON USED). IVUS WAS DONE. THE REPORT STATED THERE WERE HARD SECTIONS OBSERVED DURING IMPLANTATION AND THAT THE PHYSICIAN WAS CAREFUL NOT TO RUPTURE THE VESSEL. THE RESIDUAL STENOSIS WAS 25%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. AN ACT OF 328 WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS DE MEXICO NA I0306057

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R 3.ASPIRIN, 4.ARGATROBAN,| 1.HEPARIN, 2.TICLOPIDINE HYDROCHLORIDE,| 2.5/15 MM BALLOON.