BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MO.MA ULTRA

    MDR report key: 5755329 · Received June 28, 2016

    Report

    Report Number
    3004066202-2016-00188
    Event Type
    Injury
    Date Received
    June 28, 2016
    Date of Event
    September 23, 2015
    Report Date
    June 30, 2016
    Manufacturer
    INVATEC SPA
    Product Code
    NTE
    PMA / PMN Number
    K092177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AVERAGE AGE. MAJORITY GENDER. DATE JOURNAL WAS ACCEPTED STUDY TITLE CLINICAL ANALYSIS COMPARING EFFICACY BETWEEN A DISTAL FILTER PROTECTION DEVICE AND PROXIMAL BALLOON OCCLUSION DEVICE DURING CAROTID ARTERY STENTING JONG HYEOK LEE, M.D., HEE EON SOHN, M.D., SEUNG YOUNG CHUNG, M.D., MOON SUN PARK, M.D., SEONG MIN KIM, M.D., DO SUNG LEE, M.D. DEPARTMENT OF NEUROSURGERY, EULJI UNIVERSITY HOSPITAL, COLLEGE OF MEDICINE, EULJI UNIVERSITY, DAEJEON, KOREA J KOREAN NEUROSURG SOC 58 (4) : 316-320, 2015. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION TO EVENT DESCRIPTION: OBJECTIVE: THE MAIN CONCERN DURING TRANSFEMORAL CAROTID ARTERY STENTING (CAS) IS PREVENTING CEREBRAL EMBOLUS DISLODGEMENT. WE COMPARED CLINICAL OUTCOMES AND INTRAPROCEDURAL EMBOLIZATION RATES OF CAS USING A DISTAL FILTER PROTECTION DEVICE OR PROXIMAL BALLOON OCCLUSION DEVICE. METHODS: FROM JANUARY 2011 TO MARCH 2015, A SERIES OF 58 PATIENTS WITH SYMPTOMATIC OR ASYMPTOMATIC INTERNAL CAROTID ARTERY STENOSIS =70% WERE TREATED WITH CAS WITH EMBOLIC PROTECTION DEVICE IN SINGLE CENTER. ALL PATIENTS UNDERWENT POST-CAS DIFFUSION-WEIGHTED MAGNETIC RESONANCE IM¬AGING (DW-MRI) TO DETECT NEW ISCHEMIC LESIONS. WE COMPARED CLINICAL OUTCOMES AND POSTPROCEDURAL EMBOLIZATION RATES. RESULTS: CAS WAS PERFORMED IN ALL 61 PATIENTS. DISTAL FILTER PROTECTION SUCCESS RATE WAS 96.6% (28/29), WHOSE MEAN AGE WAS 70.9 YEARS, AND MEAN STENOSIS WAS 81%. THEIR PREPROCEDURAL INFARCTION RATE WAS 39% (11/28). SUBSEQUENT DW-MRI REVEALED 96 NEW ISCHEMIC LESIONS IN 71% (20/28) PATIENTS. IN CONTRAST, THE PROXIMAL BALLOON OCCLUSION DEVICE SUCCESS RATE WAS 93.8% (30/32), WHOSE MEAN AGE WAS 68.8 YEARS AND MEAN STENOSIS WAS 86%. PREPROCEDURE INFARCTION RATE WAS 47% (14/30). DW-MRI REVEALED 45 NEW ISCHEMIC LESIONS IN 57% (17/30) PATIENTS. COMPARED WITH DISTAL FILTER PROTECTION DEVICE, PROXIMAL BALLOON OCCLUSION DEVICE RESULTED IN FEWER ISCHEMIC LESIONS PER PATIENT (P=0.028). IN EACH GROUP, TYPE OF STENT DURING CAS HAD NO SIGNIFICANT EFFECT ON NUMBER OF PERIPROCEDURAL EMBOLISMS. ONLY 2 NEUROLOGIC EVENTS OCCURRED IN THE SUCCESSFULLY TREATED PATIENTS (ONE FROM EACH GROUP). CONCLUSION: TRANSFEMORAL CAS WITH PROXIMAL BALLOON OCCLUSION DEVICE ACHIEVES GOOD RESULTS. COMPARED WITH DISTAL FILTER PROTECTION, PROXIMAL BALLOON OCCLUSION MIGHT BE MORE EFFECTIVE IN REDUCING CEREBRAL EMBOLISM DURING CAS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    EVENT REPORTED THROUGH LITERATURE REVIEW BACKGROUND: IMPLANTATION OF A LEFT VENTRICULAR (LV) LEAD FAILS IN 5% TO10%OF PATIENTS IN WHOM CARDIAC RESYNCHRONIZATION THERAPY (CRT) IS ATTEMPTED. ALTERNATIVES FOR DELIVERY OF CRT ARE SURGICAL EPICARDIAL AND ENDOCARDIAL TRANSVENOUS LEADS. ENDOCARDIAL TRANS-SEPTAL LEAD DELIVERY IS CHALLENGING BECAUSE OF THE ABSENCE OF DEDICATED EQUIPMENT DESIGNED FOR THIS PROCEDURE. OBJECTIVE: THE PURPOSE OF THIS STUDY WAS TO DESCRIBE A NEW TECHNIQUE FOR DELIVERY OF A TRANS-SEPTAL LV LEAD. METHODS: THIS DUAL APPROACH FROM THE RIGHT FEMORAL VEIN AND LEFT SUBCLAVIAN VEIN INVOLVES USE OF AN ENDRYS TRANS-SEPTAL NEEDLE AND MULLINS SHEATH TO DELIVER A GOOSENECK SNARE FROM THE LEFT SUBCLAVIAN VEIN INTO THE RIGHT ATRIUM THAT CAN THEN BE USED TO DELIVER A DEFLECTABLE SHEATH INTO THE LEFT ATRIUM. AN ACTIVE FIXATION LEAD IS ADVANCED INTO THE LV THROUGH THE SHEATH AND SCREWED INTO THE LATERAL WALL. RESULTS: THE PROCEDURE WAS PERFORMED SUCCESSFULLY IN 12 PATIENTS IN WHOM TRANSVENOUS LV LEAD IMPLANTATION HAD PREVIOUSLY FAILED. THE ENDRYS TRANS-SEPTAL NEEDLE, IDEALLY SUITED FOR THIS TECHNIQUE, FACILITATED PASSAGE OF THE GOOSENECK SNARE INTO THE LEFT ATRIUM WITH NO DIFFICULTY. MEDIAN PROCEDURE TIME WAS 148 MINUTES (INTERQUARTILE RANGE [IQR]113¿176 MINUTES),AND MEDIAN FLUOROSCOPY TIME WAS 16 MINUTES (IQR10¿19 MINUTES). THERE WAS NO NEED FOR REPEAT PROCEDURES AFTER MEDIAN FOLLOW-UP OF 97 DAYS (IQR36¿313 DAYS). CONCLUSION THIS APPROACH USING AN ENDRYS NEEDLE AND A GOOSE-NECK SNARE PROVIDES ARE LIABLE AND EFFECTIVE ALTERNATIVE TECHNIQUE FOR DELIVERY OF AN ENDOCARDIAL LV LEAD THAT IS DELIVERED EASILY THROUGH A DEFLECTABLE SHEATH INSERTED TRANS-SEPTALLY INTO THE LV. PATIENTS IN THE STUDY HAVE HISTORY OF DIABETES MELLITUS, HYPERTENSION, DYSLIPIDEMIA, ATRIAL FIBRILLATION, HISTORY OF CARDIOVASCULAR DISEASE. PATIENT PRESENTED FOR STUDY WITH CEREBRAL INFARCTION, TIA AND DEGREE OF CAROTID ARTERY STENOSIS. FROM JANUARY 2011 TO MARCH 2015, 61 PATIENTS WITH SEVERE CAROTID LESIONS (SYMPTOMATIC AND ASYMPTOMATIC) WERE SELECTED FOR CAS WITH EITHER SPIDER-FXTM (COVIDIEN, (B)(4)) OR MO.MA ULTRA (MEDTRONIC, (B)(4)) AS THE DISTAL FILTER PROTECTION DEVICE OR PROXIMAL BALLOON OCCLUSION DEVICE, RESPECTIVELY. THE INCLUSION AND EXCLUSION CRITERIA AND THEIR ADAPTATION FOR CAS WERE DESIGNED IN ACCORDANCE WITH THE NORTH AMERICAN SYMPTOMATIC CAROTID ENDARTERECTOMY TRIAL STANDARDS. SYMPTOMATIC CAROTID ARTERY STENOSIS EXCEEDED 50% AND ASYMPTOMATIC CASES EXCEEDED 70% OF CAROTID STENOSIS RATE1). PASSING THE INSTRUMENT THROUGH LESIONS WAS IMPOSSIBLE IN THREE PATIENTS, RESULTING IN TECHNICAL FAILURE IN, 1 PATIENT IN THE DISTAL FILTER PROTECTION DEVICE GROUP AND 2 PATIENTS IN THE PROXIMAL BALLOON OCCLUSION DEVICE GROUP. WE USED THREE DIFFERENT TYPES OF CAROTID ARTERY STENTS : THE PRO¬TÉGÉ EVERFLEXTM (EV3 INC., (B)(4)) AS THE OPEN-CELL TYPE; WALLSTENT (BOSTON SCIENTIFIC CORP., (B)(4)) AS THE CLOSED-CELL TYPE; AND CRISTALLO IDEALE (INVATEC, (B)(4)) AS THE MIXED-CELL TYPE. ISCHEMIC NEUROLOGIC EVENTS WERE OBSERVED IN 2 PATIENTS (3.6%) IN THE ENTIRE STUDY POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409287 MO.MA ULTRA CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR