BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 3031106 · Received April 11, 2006

    Report

    Report Number
    9616099-2006-00409
    Event Type
    Injury
    Date Received
    April 11, 2006
    Date of Event
    September 26, 2005
    Report Date
    April 11, 2006
    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 COMPLAINT WAS RECEIVED FROM THE (B)(4) CLINICAL STUDY. THIS (B)(6) FEMALE PATIENT HAD THE FOLLOWING MEDICAL HISTORY: SILENT ISCHEMIA, PRIOR PCI, HYPERTENSION AND LIPID METABOLISM ABNORMALITY. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN. THE TARGET LESION WAS AN IN-STENT RESTENOSIS OF A BARE METAL STENT (COMPETITOR'S STENT: DETAILS UNKNOWN). THE VESSEL WAS ECCENTRIC, DIFFUSED, OSTIUM AND BIFURCATED. IT WAS NOT CALCIFIED OR TORTUOUS. AHA/ACC CLASSIFICATION OF THE VESSEL WAS A TYPE C. THERE WAS 71.0% STENOSIS. MEDICATIONS ADMINISTERED PRIOR TO THE PROCEDURE INCLUDED ASPIRIN AND TICLOPIDINE HYDROCHLORIDE. IT WAS AN ELECTIVE CASE. FEMORAL APPROACH WAS CHOSEN FOR THE PROCEDURE. HEPARIN WAS ADMINISTERED FOR THE PROCEDURE. FIRST CYPHER (3.5 X 23MM) (LOT I0205116) WAS IMPLANTED AT 20 ATMOSPHERES (ATMS) FOR 15 SECONDS BY DIRECT STENTING. THE 2ND CYPHER (3.5 X 18MM) (LOT I0205146) WAS IMPLANTED AT 22 ATM FOR 15 SECONDS AT THE PROXIMAL END OF THE INITIALLY IMPLANTED CYPHER STENT. THE STENTS WERE OVERLAPPING. POST-DILATION WAS NOT CONDUCTED. IVUS WAS CONDUCTED. TIMI FLOW BEFORE AND AFTER THE PROCEDURE WAS 3. THE RESIDUAL % OF STENOSIS WAS 7%. POST PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND TICLOPIDINE HYDROCHLORIDE. APPROXIMATELY FOUR MONTHS LATER, THE PATIENT COMPLAINED OF CHEST PAIN AND VISITED THE HOSPITAL. THE FOLLOWING DAY, THE PATIENT WAS FERRIED TO ANOTHER HOSPITAL. CORONARY ANGIOGRAPHY WAS CONDUCTED AND RESTENOSIS WAS OBSERVED INSIDE BOTH OF THE IMPLANTED CYPHER STENTS. THERE WAS 99% STENOSIS. TO TREAT THE RESTENOSIS, PCI WAS CONDUCTED. BALLOON ANGIOPLASTY WAS CONDUCTED WITH A BALLOON (4.0MM/LENGTH UNKNOWN) AT 12 ATM. INFLATION TIME WAS UNKNOWN. THE FLOW OF THE VESSEL WAS CONFIRMED. THE RESIDUAL % OF STENOSIS WAS 20%. CLINICAL IMPROVEMENT WAS OBSERVED. TIMI FLOW OF 3 WAS OBSERVED. THE FOLLOWING DAY, A CABG WAS CONDUCTED. SVG WAS USED TO GRAFT THE DISTAL END OF THE MID LEFT ANTERIOR DESCENDING (LAD), DISTAL END OF THE 1ST DIAGONAL, AND THE MID PORTION OF THE POSTEROLATERAL (PL). TIMI FLOW OF 3 WAS CONFIRMED. THE PHYSICIAN NOTED THAT IS IT UNKNOWN IF THE RESTENOSIS WAS RELATED TO THE BARE METAL STENT. THIS DEVICE CJS 23350 (LOT I0205116) IS DISTRIBUTED OUTSIDE THE UNITED STATED; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT CXS 23350. THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 9616099-2006-00410. THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED TWO CYPHER STENTS IN THE LEFT MAIN. APPROXIMATELY FOUR MONTHS LATER, THE PATIENT HAD RESTENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK CYPHER STENT NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R ISOSORBIDE MONONITRATE| TICLOPIDINE HYDROCHOLORIDE| ASPIRIN| HEPARIN