BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER FX

    MDR report key: 6044745 · Received October 20, 2016

    Report

    Report Number
    2183870-2016-00647
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    August 1, 2016
    Report Date
    September 21, 2016
    Manufacturer
    COVIDIEN LLC
    Product Code
    NTE
    PMA / PMN Number
    K111010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL: EUROINTERVENTION. JOURNAL TITLE: NOVEL PARADIGM IN CAROTID REVASCULARISATION: PROSPECTIVE EVALUATION OF ALL-COMER PERCUTANEOUS CAROTID REVASCULARISATION IN SYMPTOMATIC AND INCREASED-RISK ASYMPTOMATIC CAROTID ARTERY STENOSIS USING CGUARD¿ MICRONET-COVERED EMBOLIC PREVENTION STENT SYSTEM NOVEL PARADIGM IN CAROTID REVASCULARISATION YEAR OF PUBLICATION: 2016 ISSUE #: 12 EUROINTERVENTION 2016;12:E658-E670 ¦ PUBLISHED ONLINE AHEAD OF PRINT MAY 2016 ¦ PUBLISHED ONLINE E-EDITION AUGUST 2016. DOI: 10.4244/EIJY16M05_02.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENTS HAD HISTORY OF CORONARY ARTERY DISEASE, PREVIOUS MI, PRIOR PCI, PRIOR CABG, ATRIAL FIBRILLATION. THE ICA WAS TREATED DURING INDEX PROCEDURE. AIMS: OUR AIM WAS TO DETERMINE PERIPROCEDURAL AND 30-DAY CLINICAL SAFETY AND EFFICACY OF THE CGUARD MICRONET-COVERED EMBOLIC PREVENTION CAROTID STENT SYSTEM (MN-EPS) IN ROUTINE USE FOR UNSELECTED CAROTID STENOSIS (CS) PATIENTS UNDERGOING CAS, AS WELL AS FEASIBILITY OF MN-EPS POST-DILATATION OPTIMISATION TO MINIMISE RESIDUAL STENOSIS AFTER CAS. METHODS AND RESULTS: THIS WAS A NON-INDUSTRY-FUNDED, PROSPECTIVE ACADEMIC STUDY IN ALL-REFERRALS TRACKED SYMPTOMATIC AND ASYMPTOMATIC CS. IN ASYMPTOMATIC LESIONS, INTERVENTION WAS MANDATED ONLY IN CASE OF INCREASED STROKE RISK CS FEATURES. THERE WAS INDEPENDENT NEUROLOGIST EVALUATION BEFORE CAS, AT 48 HOURS AND 30 DAYS. THERE WAS EXTERNAL SOURCE DATA VERIFICATION, ANGIOGRAPHIC CORE LAB, AND STATISTICAL ANALYSIS. OVER 11 MONTHS, 108 REFERRALS WERE RECOMMENDED BY THE NEUROVASCULAR TEAM FOR REVASCULARISATION: 101 (51-86 YEARS, 55 SYMPTOMATIC, EVOLVING STROKE IN NINE) UNDERWENT 106 (100% MN-EPS USE) NEUROPROTECTION DEVICE-ASSISTED (46% PROXIMAL, 54% DISTAL) CAS; CEA WAS PERFORMED IN SEVEN. MN-EPS DEVICE SUCCESS WAS 99.1%. ANGIOGRAPHIC DIAMETER STENOSIS WAS REDUCED FROM 83 +/- 9% TO 6.7 +/- 5% (P<(><<)>0.001). NO MN-EPS FORESHORTENING/ELONGATION OCCURRED (30 MM LONG WAS 29.82 +/- 68 MM; 40 MM LONG WAS 39.89 +/- 0.59 MM). THE PERIPROCEDURAL DEATH/MAJOR STROKE/MI RATE WAS 0%. ONE EVENT, WITH NO CHANGE IN NIHSS OR MODIFIED RANKIN SCALE AND NO CLINICAL SEQUEL, WAS ADJUDICATED BY THE CLINICAL EVENTS COMMITTEE AS MINOR STROKE (0.9%). BY 30 DAYS THERE WERE NO NEW EVENTS (0%). CONCLUSIONS: THESE INCREASED RISK CONSECUTIVE PATIENT DATA INDICATE SAFETY AND EFFICACY OF ROUTINE MN-EPS USE IN ACHIEVING ENDOVASCULAR RECONSTRUCTION ACROSS ALL-COMER CS LESION SUBSETS, AND ARE CONSISTENT WITH MN-EPS PROTECTION AGAINST CEREBRAL EVENTS EXTENDING THROUGHOUT THE STENT HEALING PERIOD. CAS WAS ROUTINELY PERFORMED USING THE TRANSFEMORAL ROUTE. FOUR PATIENTS WITH SYMPTOMATIC CAROTID STENOSIS AND ANGIOGRAPHICALLY SEVERE CAD UNDERWENT ONE-STAGE CORONARY PCI AND CAS. MEAN ANGIOGRAPHIC STENOSIS SEVERITY WAS 83 +/- 9%. FIFTY-SEVEN (54%) PROCEDURES WERE PERFORMED UNDER DISTAL NPD INCLUDING SPIDER FX (COVIDIEN/MEDTRONIC, (B)(4)) IN 31, EPI FILTERWIRE EZ (BOSTON SCIENTIFIC, (B)(4)) IN 15, AND EMBOSHIELD NAV (ABBOTT VASCULAR, (B)(4)) IN 11. PROXIMAL BRAIN PROTECTION BY TEMPORARY FLOW REVERSAL WAS EMPLOYED IN 49 CAS PROCEDURES (46%) USING EITHER THE GORE FLOW REVERSAL SYSTEM (W.L. GORE AND ASSOCIATES INC., (B)(4)) OR MO.MA SYSTEM (MEDTRONIC, (B)(4)) EMPLOYED ROUTINELY TO REVERSE RATHER THAN BLOCK INDEX ICA FLOW (N=43). PROXIMAL VS. DISTAL NPD USE WAS MORE FREQUENT FOR SYMPTOMATIC LESION TREATMENT (31/55 VS. 18/51, P=0.03) MACROSCOPIC EVIDENCE OF DEBRIS IN THE NPD FILTER (OR, IN THE CASE OF THE MO.MA SYSTEM, BASKET) WAS PRESENT IN 19 (17.9%) PROCEDURES CONSISTENT WITH THE RATIONALE TO EMPLOY NPDS ROUTINELY FOR CEREBRAL PROTECTION PRIOR TO THE MN-EPS EMBOLIC PREVENTION EFFECT. IN 16 CAS (15.1%), TRANSIENT DOPAMINE INFUSION WAS USED TO CONTROL NO DEATH/MAJOR STROKE OR MI (0%) OCCURRED AT 48 HOURS AND PRIOR TO DISCHARGE. ONE PATIENT, WITH SYMPTOMATIC RICA STENOSIS (MINOR RIG HT-HEMISPHERIC STROKE TWO MONTHS PRIOR TO CAS), HAD HYPOTONIA AND TRANSIENT, FLUCTUATING COGNITIVE DYSFUNCTION AT 24-48 HOURS AFTER CAS. THE PATIENT HAD ADDITIONAL NEUROLOGIC EVALUATION ON DISCHARGE (DAY 7) THAT SHOWED NO CHANGE IN NIHSS AND MODIFIED RANKIN SCALE AGAINST 48-HR (AND BASELINE) EVALUATION. CT SCAN ON DAY 2 SHOWED NO NEW CEREBRAL LESIONS BUT DAY 6 CT REVEALED AN EXTENSION OF THE PRIOR LESION IN THE RIGHT HEMISPHERE. THIS EVENT WAS CEC-ADJUDICATED AS MINOR STROKE IN RELATION TO CAS. THUS, THE PERIPROCEDURAL MINOR STROKE RATE WAS 0.9%. NO ASYMPTOMATIC OR SYMPTOMATIC PATIENT AT BASELINE SHOWED DETERIORATION BY NIHSS OR MODIFIED RANKIN SCALE SCORE AT 48 HOURS OR 30 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696213 SPIDER FX CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE COVIDIEN LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR