BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER RX

    MDR report key: 5751974 · Received June 27, 2016

    Report

    Report Number
    2183870-2016-00475
    Event Type
    Injury
    Date Received
    June 27, 2016
    Date of Event
    May 22, 2015
    Report Date
    May 29, 2016
    Manufacturer
    COVIDIEN
    Product Code
    NFA
    PMA / PMN Number
    K063785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY TITLE: ACUTE KIDNEY INJURY IN PATIENTS WITH CHRONIC KIDNEY DISEASE UNDERGOING INTERNAL CAROTID ARTERY STENT IMPLANTATION MICHAEL DONAHUE, MD; GABRIELLA VISCONTI, MD; AMELIA FOCACCIO, MD; LUCIO SELVETELLA, MD; MARIA BALDASSARRE, MD; CHIARA VIVIANI ANSELMI, PHD; CARLO BRIGUORI, MD, PHD J A C C : CARDI O V AS C ULAR I NT E R V E N T IONS V O L . 8 , N O . 1 1 , 2 0 1 5 ª 20 1 5 B Y THE AM E R I C AN COL L E G E OF CARDI O L OGY FOUNDAT ION I S SN 1 9 3 6 - 8 7 9 8 / $ 3 6 . 0 0 P U B LI S H ED B Y E L S E VI E R INC . H T T P : / / D X . D O I . O R G / 1 0 . 1 0 1 6 / J . J C I N . 2 0 1 5 . 0 5 . 0 2 1

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    OBJECTIVES THIS STUDY SOUGHT TO INVESTIGATE ACUTE KIDNEY INJURY (AKI) FOLLOWING CAROTID ARTERY STENTING (CAS). BACKGROUND FEW DATA EXIST ON AKI FOLLOWING CAS. METHODS THIS STUDY EVALUATED 126 CHRONIC KIDNEY DISEASE (CKD) PATIENTS WHO UNDERWENT CAS. THE RISK FOR CONTRAST INDUCED AKI WAS DEFINED BY THE MEHRAN SCORE. HEMODYNAMIC DEPRESSION (I.E., PERIPROCEDURAL SYSTOLIC BLOOD PRESSURE <(><<)>90 MM HG OR HEART RATE <(><<)>60 BEATS/MIN), AKI (I.E., AN INCREASE OF 0.3 MG/DL IN THE SERUM CREATININE CONCENTRATION AT 48 H), AND 30-DAY MAJOR ADVERSE EVENTS (INCLUDING DEATH, STROKE, AND ACUTE MYOCARDIAL INFARCTION) WERE ASSESSED. RESULTS AKI OCCURRED IN 26 PATIENTS (21%). ALTHOUGH BASELINE KIDNEY FUNCTION AND CONTRAST VOLUME WERE SIMILAR IN THE AKI GROUP AND THE NON-AKI GROUP, THE RISK SCORE WAS HIGHER (10.3 VS. 8.3; P ¼ 0.032), AND HEMODYNAMIC DEPRESSION (MOSTLY DUE TO HYPOTENSION) (65.5% VS. 35%; P ¼ 0.005) WAS MORE COMMON IN THE AKI GROUP. THE THRESHOLD OF HEMODYNAMIC DEPRESSION DURATION FOR AKI DEVELOPMENT WAS 2.5 MIN (SENSITIVITY 54%, SPECIFICITY 82%). INDEPENDENT PREDICTORS OF AKI WERE HEMODYNAMIC DEPRESSION (ODDS RATIO [OR]: 4.01; 95% CONFIDENCE INTERVAL [CI]: 1.07 TO 15.03; P ¼ 0.009), RISK SCORE (OR: 1.29; 95% CI: 1.03 TO 1.60; P ¼ 0.024), AND MALE SEX (OR: 6.07; 95% CI: 1.18 TO 31.08; P ¼ 0.021). INDEPENDENT PREDICTORS OF 30-DAY MAJOR ADVERSE EVENTS THAT OCCURRED MORE OFTEN IN THE AKI GROUP (19.5% VS. 7%; P ¼ 0.058) WERE AKI (HR: 4.83; 95% CI: 1.10 TO 21.24; P ¼ 0.037) AND HEMODYNAMIC DEPRESSION (HR: 5.58; 95% CI: 1.10 TO 28.31; P ¼ 0.038). CONCLUSIONS AKI IN CKD PATIENTS UNDERGOING CAS IS MOSTLY DUE TO HEMODYNAMIC DEPRESSION AND IS ASSOCIATED WITH A HIGHER 30-DAY MAJOR ADVERSE EVENTS RATE. TWELVE PERCENT OF PATIENTS IN STUDY ARE ACTIVE SMOKERS. PATIENTS HAVE A HISTORY OF HYPERTENSION, HYPERCHOLESTEROLEMIA, DIABETES MELLITUS, CORONARY ARTERY DISEASE, CAROTID OCCLUSION AND PREVIOUS ENDARTERECTOMY. SELF-EXPANDING STENTS WERE USED IN ALL INSTANCES. STENTS WERE CLASSIFIED ACCORDING TO ALLOY: BRAIDED ELGILOY (CAROTID WALLSTENT, BOSTON SCIENTIFIC, (B)(4)); AND NITINOL STENTS (X-ACT AND ACCULINK [ABBOTT VASCULAR DEVICES, (B)(4)]; PRECISE [CORDIS, (B)(4)]; CRYSTALLO IDEALE [MEDTRONIC INC., (B)(4)]; PROTEGÈ (EV3, (B)(4)); SINUS CAROTID RX (OPTIMED, (B)(4)). FURTHERMORE, STENTS WERE DIVIDED ACCORDING TO CELL DESIGN: CLOSED CELLS: CAROTID WALLSTENT AND X-ACT; OPEN CELLS: PRECISE AND PROTEGÈ; AND HYBRID: CRYSTALLO IDEALE, AND SINUS CAROTID RX. BALLOON POSTDILATION WAS ROUTINELY PERFORMED WITH A 5.0-MM BALLOON. THIS STUDY INCLUDED 126 CKD PATIENTS. FORTY PATIENTS (32%) WERE SYMPTOMATIC FOR CAROTID ARTERY DISEASE. MEAN ARTERIAL PRESSURE WAS 90 _ 6 MM HG. MEAN HEART RATE WAS 73 _ 10 BEATS/MIN, AND 6 PATIENTS (4.8%) WERE BRADYCARDIC BEFORE THE PROCEDURE. IN-HOSPITAL AND 30-DAY MAE. IN-HOSPITAL AND 30-DAY MAE OCCURRED IN 12 PATIENTS (9.5%) AND WERE MORE COMMON IN THE AKI GROUP THAN IN THE NON-AKI GROUP (5 OF 26 [19.5%] VS. 7 OF 100 [7%]; OR: 6.39; 95% CI: 1.01 TO 40.48; P ¼ 0.058). THE HIGHER MAE EVENTS RATE IN THE AKI GROUP WAS DRIVEN BY THE HIGHER DEATH RATE (3 OF 26 [11.5%] VS. 2 OF 100 [2%]; P ¼ 0.026), WHEREAS THE RATE OF NEUROLOGICAL COMPLICATION WAS SIMILAR IN THE 2 GROUPS. MAJOR BLEEDING OCCURRED IN 1 PATIENT IN THE AKI GROUP (3.8%) AND IN NONE IN THE NON-AKI GROUP (P ¼ 0.21). INDEPENDENT PREDICTORS OF 30-DAY MAE WERE AKI (HR: 4.83; 95% CI: 1.10 TO 21.24; P ¼ 0.037) AND HEMODYNAMIC DEPRESSION (HR: 5.58; 95% CI: 1.10 TO 28.31; P ¼ 0.038). HEMODYNAMIC DEPRESSION 2.5 MIN OCCURRED IN 5 OF 12 PATIENTS (41.5%) WITH MAE AND IN 14 OF 114 PATIENTS (12.5%) WITHOUT MAE (OR: 5.01; 95% CI: 1.42 TO 18.29; P ¼ 0.019).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404635 SPIDER RX DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC NFA COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention