BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1153063 · Received September 8, 2008

    Report

    Report Number
    9616099-2008-02183
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    November 30, 2007
    Report Date
    August 19, 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

    A DEVICE HISTORY REPORT REVIEW WAS CONDUCTED AND THIS LOT OF PRODUCTS MET THE REQUIREMENTS PER THE APPLICABLE QUALITY MANUFACTURING PLAN. EMBOLIC STROKE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. ALTHOUGH THE REPORTED STROKE COULD NOT CONCLUSIVELY BE DETERMINED THE ACT OF MANIPULATING THE DEVICES USED TO PERFORM ANGIOPLASTY WITHIN THE VASCULATURE COULD HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE STUDY INDICATED THAT A PATIENT EXPERIENCED AN EMBOLIC STROKE AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT'S HISTORY IS SIGNIFICANT FOR HYPERLIPIDEMIA, FAMILY HISTORY AND REMOTE HISTORY OF TOBACCO ABUSE. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA PECTORIS WITH RESTING ECG CHANGES. THE LESION WAS DESCRIBED DE NOVO AND 99% STENOSED. THE LESION WAS PRE-DILATED WITH A 2.5 X 12M BALLOON AT 10ATMS FOLLOWED BY THE DEPLOYMENT OF A 2.75MM X 23MM CYPHER SELECT STENT AT 18ATMS. THE STENT WAS POST-DILATED FOR OPTIMAL EXPANSION WITH A 3.0MM X 15MM BALLOON. THE PATIENT WAS DISCHARGED HOME THE DAY OF THE PROCEDURE. THE PATIENT COMPLAINED OF BLURRED DOUBLE VISION SINCE THE PCI, THE SYMPTOMS WERE EVALUATED PRIOR TO DISCHARGE AND "FOUND NOTHING IN THE WAY OF A FOCAL LESION". APPROXIMATELY ONE MONTH AFTER THE PROCEDURE, THE PATIENT WENT TO THE EMERGENCY ROOM WITH COMPLAINTS OF CHEST PAIN AND BLURRED VISION. A CT SCAN PERFORMED WAS NORMAL AND THE PATIENT WAS REFERRED TO NEUROLOGY. AN MRI WAS ALSO PERFORMED WITH RESULTS WITHIN NORMAL LIMITS, AN ECHOCARDIOGRAM WAS NEGATIVE FOR EMBOLI, A CRANIAL DOPPLER WAS NORMAL AND A MYOVIEW PERFORMED WAS NORMAL. THE SITE REPORTED THE INITIAL EVENT THAT OCCURRED AFTER PCI AS HAVING BEEN AN EMBOLIC STROKE.

    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 13257278

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention GUIDING CATHETER SIZE (FR) 6| WHISPER WIRE