BEUDAMED
    FDA Adverse Event Death Summary report: N

    MO.MA

    MDR report key: 3954464 · Received July 24, 2014

    Report

    Report Number
    3004066202-2014-00112
    Event Type
    Death
    Date Received
    July 24, 2014
    Date of Event
    March 10, 2010
    Report Date
    June 25, 2014
    Manufacturer
    INVATEC SPA
    Product Code
    NTE
    PMA / PMN Number
    K092177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: (ROOT CAUSE UNDETERMINED). INHERENT RISK OF PROCEDURE ¿ (DEATH). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED - (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). (ROOT CAUSE UNDETERMINED). UNABLE TO CONFIRM COMPLAINT - (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). (B)(4).

    Description of Event or Problem · 1

    THIS STUDY (MULTICENTER ARMOUR (PROXIMAL PROTECTION WITH THE MO.MA DEVICE DURING CAROTID STENTING)) EVALUATED THE 30-DAY SAFETY AND EFFECTIVENESS OF THE MO.MA PROXIMAL CEREBRAL PROTECTION DEVICE UTILIZED TO TREAT HIGH SURGICAL RISK PATIENTS UNDERGOING CAROTID ARTERY STENTING (CAS). THIS PROSPECTIVE REGISTRY ENROLLED 262 SUBJECTS BETWEEN SEPTEMBER 2007 AND FEBRUARY 2009. THERE WERE 37 ROLL-IN SUBJECTS ENROLLED PRIOR TO THE PIVOTAL PHASE. THE INTENTION TO TREAT (ITT) POPULATION CONSISTED OF ALL SUBJECTS ENROLLED IN THE TRIAL REGARDLESS OF SUBSEQUENT TREATMENT, EXCLUDING ROLL-IN SUBJECTS (N = 225). SUBJECTS UNDERWENT CAS USING THE MO.MA DEVICE. THE PRIMARY ENDPOINT, MYOCARDIAL INFARCTION, STROKE, OR DEATH THROUGH 30 DAYS WAS COMPARED TO A PERFORMANCE GOAL OF 13% DERIVED FROM TRIALS UTILIZING DISTAL EMBOLIC PROTECTION DEVICES (EPD). BASELINE CAROTID DUPLEX ULTRASONOGRAPHY AND NEUROLOGICAL EXAMINATIONS WERE PERFORMED PRIOR TO THE CAS PROCEDURE. THE SUBJECTS RECEIVED ANTICOAGULATION/ANTIPLATELET THERAPY AS DIRECTED BY THE CURRENT STANDARD OF CARE FOR CAS. ACTIVATED CLOTTING TIME (ACT) WAS MONITORED DURING THE PROCEDURE AND MAINTAINED AT GREATER THAN 250 SEC THROUGHOUT THE INTERVENTION. PRE-PROCEDURAL ANGIOGRAPHY OF THE AORTIC ARCH, BILATERAL COMMON, INTERNAL, AND EXTERNAL CAROTID ARTERIES AND INTRACRANIAL VESSELS WAS COMPLETED. ANGIOGRAPHIC DOCUMENTATION INCLUDED ANTEROPOSTERIOR AND LATERALPLANE VIEWS, BOTH PRE-AND POST-PROCEDURE, OF THE IPSILATERAL CAROTID AND CEREBRAL HEMISPHERES. UTILIZING RETROGRADE FEMORAL ACCESS, THE MO.MA DEVICE WAS PLACED OVER A STIFF 035" GUIDE WIRE POSITIONED IN THE ECA. SYSTEMIC ANTICOAGULATION WAS OBTAINED WITH ADMINISTRATION OF HEPARIN OR BIVALIRUDIN. THE PROCEDURE WAS PERFORMED WITH LOCAL ANESTHESIA AND MINIMAL SEDATION. THE MO.MA DEVICE WAS POSITIONED AND CEREBRAL PROTECTION WITH FLOW CESSATION WAS ESTABLISHED PRIOR TO GUIDE-WIRE OR DEVICE PLACEMENT ACROSS THE CAROTID STENOSIS. SLOW INFLATION OF THE ECA AND CCA BALLOONS WAS OBSERVED UNDER FLUOROSCOPY UNTIL OCCLUSION WAS INDICATED BY THE CHANGE IN BALLOON SHAPE FROM CIRCULAR TO CYLINDRICAL. FLOW CESSATION WAS CONFIRMED BY STAGNATION OF 5 CC OF SLOWLY INJECTED CONTRAST/ SALINE MIX AND THE ESTABLISHMENT OF CAROTID ARTERY BACK PRESSURE. PRE-DILATATION OF THE LESION WITH BALLOON ANGIOPLASTY WAS OPTIONAL AND LEFT TO OPERATOR DISCRETION. STENT DEPLOYMENT AND ANY POST DILATION WERE THEN COMPLETED. BALLOONS AND/OR W IRES WERE THEN REMOVED. ASPIRATION OF 60 CC (3 SYRINGES OF 20 CC) OF BLOOD WAS COMPLETED WITH THE LAST 20 CC FILTERED THROUGH A 40 UM FILTER TO EVALUATE FOR ATHEROTHROMBOTIC DEBRIS. IF DEBRIS WAS NOTED, ADDITIONAL 20CC ASPIRATES WERE COMPLETED UNTIL NO FURTHER DEBRIS WAS VISIBLE. SUBJECTS WERE MONITORED FOR ANY SIGNS OF INTOLERANCE DURING ASPIRATION. RESTORATION OF ANTEGRADE BLOOD FLOW WAS THEN RE-ESTABLISHED BY DEFLATION OF THE MO.MA DEVICE BALLOONS AND FINAL ANGIOGRAPHY WAS THEN COMPLETED. ALL SUBJECTS UNDERWENT NEUROLOGICAL ASSESSMENTS DURING THE PROCEDURE TO DETERMINE IF ANY ISCHEMIC HEMISPHERIC DEFICITS DEVELOPED. HEMODYNAMICS, INCLUDING SYSTEMIC PRESSURE AND CAROTID ARTERY BACK PRESSURE OBTAINED THROUGH THE MO.MA DEVICE AFTER THE PROXIMAL BALLOON INFLATION, WERE CONTINUOUSLY MONITORED DURING THE PROCEDURE. INDEPENDENT NEUROLOGICAL EXAMINATION WAS CONDUCTED BY NIHSS CERTIFIED CLINICIANS AT BASELINE, PRIOR TO DISCHARGE, AND AT 30-DAY FOLLOW-UP. A DUPLEX ULTRASOUND EXAMINATION OF THE CAROTID STENT SITE WAS PERFORMED AT 30-DAYS POST PROCEDURE. ENDPOINTS OF STUDY: DEATH 0.8% (2/257), STROKE 1.9 % (5/257), MINOR IPSILATERAL STROKE 1.2% (3/257) AND MAJOR IPSILATERAL STROKE 0.8% (2/257). THE RESULTS OF THE TRIAL DEMONSTRATED A VERY LOW OVERALL MACCE RATE OF 2.7, WITH ALL STROKES AND MAJOR STROKE RATES OF 2.3 AND 0.9%, RESPECTIVELY. THE MACCE RATE FOR SYMPTOMATIC SUBJECTS IN THE TRIAL WAS 0.0%. THE STUDY DEMONSTRATED THAT THE MO.MA PROXIMAL CEREBRAL PROTECTION DEVICE IS SAFE AND EFFECTIVE FOR HIGH SURGICAL RISK PATIENTS UNDERGOING CAS. THE ABSENCE OF STROKE IN SYMPTOMATIC PATIENTS IS THE LOWEST RATE REPORTED IN ANY INDEPENDENTLY ADJUDICATED PROSPECTIVE MULTICENTER REGISTRY TRIAL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434016 MO.MA CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR