BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1053626 · Received May 23, 2008

    Report

    Report Number
    9616099-2008-01383
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    November 5, 2007
    Report Date
    May 3, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT PRESENTED TO THE CARDIAC CATH LAB AND 1-VESSEL DISEASE WAS FOUND. THE PRIMARY INDICATION FOR INTERVENTION WAS AN ANTERIOR WALL NON ST ELEVATION ACUTE MYOCARDIAL INFARCTION WITHIN 24 TO 72 HOURS OF PCI AND RESTING ECG CHANGES. PRE-PROCEDURE CK WAS WITHIN NORMAL LIMITS. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS AND BETA-BLOCKERS. INTRA-PROCEDURE MEDICATIONS INCLUDED UNFRACTIONATED HEPARIN. PCI WAS PERFORMED ON AN 80% DE NOVO LESION IN THE MID CIRCUMFLEX OF 15MM IN LENGTH IN A 2.25MM VESSEL DIAMETER. THE (B2) ECCENTRIC LESION WAS CHARACTERIZED WITH A SMOOTH CONTOUR, ANGULATION BETWEEN 45 TO 90 DEGREES, MODERATE CALCIFICATION AND THROMBUS ABSENT. A 2.25X18MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 16 ATM WITH SATISFACTORY RESULTS. THEN A 2.25X13MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 16 ATM TO TREAT A DISSECTION. IT WAS CLASSIFIED AS PROBABLY RELATED TO THE DEVICE. IT WAS NOT CONSIDERED A SERIOUS ADVERSE EVENT AND RESOLVED WITHOUT SEQUEL. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) III FLOW WAS RECORDED PRE AND POST-PROCEDURE, RESPECTIVELY. INTRA-VASCULAR ULTRASOUND (IVUS) WAS NOT USED. POST-PROCEDURE TROPONIN WAS GREATER THAN OR EQUAL TO 5 TIMES ABOVE THE UPPER NORMAL LIMITS AT THE 6-24 HOUR INTERVAL. THE PT WAS DISCHARGED 6 DAYS LATER. POST-PROCEDURE MEDICATIONS INCLUDED PERMANENT ASPIRIN, CLOPIDOGREL FOR 12 MONTHS, STATINS, ACE INHIBITORS AND BETA-BLOCKERS. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED PRODUCT. IT IS ALSO NOT AVAILABLE FOR TESTING AND EVALUATION.

    Description of Event or Problem · 1

    AS REPORTED BY THE STUDY, DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) IN THE MID CIRCUMFLEX, AFTER A 2.25X18MM CYPHER SELECT STENT WAS DEPLOYED, A SMALL DISSECTION (TYPE A) WAS NOTED PROXIMAL TO THE STENT. TO TREAT THE DISSECTION A 2.25X13MM CYPHER SELECT PLUS STENT WAS IMPLANTED.

    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 13275416

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| R ASPIRIN| CLOPIDOGREL| ACE INHIBITORS| BETA-BLOCKERS| INTRA-PROCEDURE MEDICATIONS INCLUDED| UNFRACTIONATED HEPARIN| STATINS| DEVICES: PILOT GUIDEWIRE| MEDICATIONS: PRE AND POST-PROCEDURE MEDICATIONS