BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1221984 · Received November 3, 2008

    Report

    Report Number
    9616099-2008-02592
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 6, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT(S) ARE NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING ROUTE SHEETS FOR THE INVOLVED LOT(S) CONFIRMED THAT THE DEVICE(S) MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ISCHEMIC STROKES ARE A KNOWN COMPLICATION ASSOCIATED WITH CAROTID ARTERY STENTING CAUSED BY AN EMBOLUS (DEBRIS OR BLOOD CLOT) THAT FORMS ELSEWHERE IN THE BODY AND TRAVELS THROUGH THE BLOODSTREAM TO THE BRAIN. LUMEN ENLARGEMENT DURING STENTING RESULTS FROM VESSELS EXPANSION AND AXIAL REDISTRIBUTION OF ATHEROMATOUS PLAQUE ALONG THE STENTED SEGMENT AND PROXIMAL AND DISTAL SEGMENTS. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE BLOOD STREAM. SUFFICIENT ANTIPLATELET THERAPY MUST BE CONDUCTED DURING AND POST PROCEDURE, TO DECREASE THE RISK OF EMBOLIC STROKES. THE FEMORAL ACCESS SITE ALSO SUFFERS VESSEL INJURY THAT CAN POTENTIALLY CAUSE AN EMBOLIC STROKE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT IS RELATED TO A MANUFACTURING ISSUE OR DEFECT OF THE DEVICE. BASED ON THE INFORMATION AVAILABLE, THERE ARE INHERENT PROCEDURAL RISKS AND PATIENT AND VESSEL FACTORS (LONG LESION LENGTH, TORTUOUS, HIGHLY CALCIFIED) THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    APPROXIMATELY THREE DAYS POST PROCEDURE, THE PATIENT EXPERIENCED A NEUROLOGICAL DEFICIT OF APHASIA WITH VISUAL FIELD LOSS OF THE RIGHT SIDE. ONSET WAS STEP LIKE AND DIAGNOSIS WAS ISCHEMIC STROKE. RECOVERY WAS PARTIAL WITH MINOR RESIDUAL. THIS FEMALE PATIENT WITH A HISTORY OF PREVIOUS TIA, PREVIOUS STROKE, CARDIAC ARRHYTHMIA, CONGESTIVE HEART FAILURE AND CORONARY ARTERY DISEASE, WAS ADMITTED FOR ANGIOGRAPHIC CAROTID EVALUATION. THE PATIENT WAS SYMPTOMATIC FOR CAROTID ARTERY DISEASE AT THE TIME OF EXAM. SHE WAS CONSIDERED HIGH RISK FOR CAROTID INTERVENTION DUE TO CONTRALATERAL CAROTID OCCLUSION. HER PRE-PROCEDURE HOSPITAL STROKE SCALE SCORE WAS 0. BASELINE MEDICATIONS INCLUDED CLOPIDOGREL AND ASPIRIN. ANGIOGRAPHY REVEALED A 90%, 20MM STENOSIS IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY (LIC). THE LESION WAS DESCRIBED AS ECCENTRIC AND SEVERELY CALCIFIED. THE VESSEL WAS DESCRIBED AS MODERATELY TORTUOUS. AN ANGIOGUARD RX DEVICE (6MM BASKET) WAS ADVANCED BEYOND THE TARGET, AND WAS DEPLOYED WITHOUT DIFFICULTY. AN 8.0 X 30MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET SITE. RESIDUAL STENOSIS WAS 20%. THE ANGIOGUARD WAS SUCCESSFULLY RETRIEVED WITHOUT INCIDENT. NO DEBRIS WAS NOTED IN THE FILTER. NO NEUROLOGICAL DEFICITS WERE APPARENT WHEN THE PATIENT LEFT THE ANGIOGRAPHY SUITE. POST-PROCEDURE MEDICATIONS INCLUDED CLOPIDOGREL AND ASPIRIN. APPROXIMATELY 2 DAYS FOLLOWING THE INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH HAVING AN ISCHEMIC STROKE. THE EVENT HAD A STEP-LIKE ONSET. NEUROLOGICAL DEFICITS INCLUDED APHASIA AND RIGHT SIDED VISUAL FIELD LOSS. THERE WAS NO EVIDENCE OF HEMIPARESIS, HEMINEGLECT OR HEMIATAXIA. THE PATIENT RECOVERED WITH MINOR RESIDUAL EFFECT. LABORATORY TESTING REVEALED A PT OF 12.8, INR 1.3, APPT 26.9 AND ACT 331.0. APPROXIMATELY 12 DAYS FOLLOWING THE INDEX PROCEDURE, THE PATIENT WAS DISCHARGED WITH A HOSPITAL STROKE SCALE SCORE OF 5 AND A STROKE SCORE OF 4. AT THE TIME OF THE 30-DAY FOLLOW-UP, THE PATIENT HAD A HOSPITAL STROKE SCALE SCORE OF 6 AND A STROKE SCORE OF 4. NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 13444446

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R ASPIRIN| CLOPIDOGREL