BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MO.MA

    MDR report key: 3954734 · Received July 24, 2014

    Report

    Report Number
    3004066202-2014-00114
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 1, 2005
    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: INHERENT RISK OF PROCEDURE ¿ (STROKE/TIA). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED- DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. NO DEVICE RETURNED. (ROOT CAUSE UNDETERMINED). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (STROKE/TIA). UNABLE TO CONFIRM COMPLAINT. (ROOT CAUSE UNDETERMINED). DATE OF PUBLICATION (MONTH AND YEAR VALID). JOURNAL OF CARDIOVASCULAR SURGERY 2005 JUN; 46(3):219-27 (J CARDIOVASC SURGE (TORINO) 2005; 46:219-27) TITLE OF ARTICLE "PRIAMUS-PROXIMAL FLOW BLOCKAGE CEREBRAL PROTECTION DURING CAROTID STENTING: RESULTS FROM A MULTICENTER (B)(4)REGISTRY."

    Description of Event or Problem · 1

    THE AIM OF THIS (B)(4) REGISTRY (PRIAMUS--PROXIMAL FLOW BLOCKAGE CEREBRAL PROTECTION DURING CAROTID STENTING) WAS TO EVALUATE THE APPLICABILITY AND EFFICACY OF THE MO.MA DEVICE FOR THE PREVENTION OF CEREBRAL EMBOLIZATION DURING CAROTID ARTERY STENTING (CAS) IN A REAL WORLD POPULATION. IN (B)(6) CENTERS, 416 PATIENTS WERE ENROLLED IN A PROSPECTIVE REGISTRY. TWO-HUNDRED AND SIXTY-FOUR SYMPTOMATIC (63.46%) WITH >50% DIAMETER STENOSIS AND 152 (36.54%) ASYMPTOMATIC PATIENTS WITH >70% DIAMETER STENOSIS WERE INCLUDED. THE MO.MA PROXIMAL FLOW BLOCKAGE EMBOLIC PROTECTION SYSTEM WAS USED TO PERFORM PROTECTED CAS, ACHIEVING CEREBRAL PROTECTION BY ENDOVASCULAR CLAMPING OF THE COMMON CAROTID ARTERY (CCA) AND OF THE EXTERNAL CAROTID ARTERY (ECA). TECHNICAL SUCCESS, DEFINED AS THE ABILITY TO ESTABLISH PROTECTION WITH THE MO.MA DEVICE AND TO DEPLOY THE STENT, WAS ACHIEVED IN 412 CASES (99.03%). ONLY IN TWO CASES IT WAS IMPOSSIBLE TO CORRECTLY POSITION THE MO. MA DUE TO SEVERE TORTUOSITY OF THE AORTIC ARCH. IN ADDITIONAL 2 CASES CEREBRAL PROTECTION COULD NOT BE ACHIEVED; IN 1 CASE BECAUSE OF A RUPTURE OF THE DISTAL BALLOON FOR EXCESSIVE INFLATION (IN THIS CASE A FILTER WAS PLACED) AND IN ANOTHER CASE BECAUSE OF THE DISLODGEMENT OF THE SYSTEM DUE TO BALLOON SLIDING BECAUSE OF INAPPROPRIATE HANDLING (IN THIS CASE THE PROCEDURE WAS SUCCESSFULLY ACCOMPLISHED). THE MEAN DURATION OF FLOW BLOCKAGE WAS 4.91+/-1.1 MIN. TRANSIENT INTOLERANCES TO FLOW BLOCKAGE WERE OBSERVED IN 24 PATIENTS (5.76%), BUT IN ALL CASES THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PERI-PROCEDURAL STROKES AND DEATHS WERE OBSERVED. COMPLICATIONS DURING HOSPITALIZATION INCLUDED 16 MINOR STROKES (3.84%), 3 TRANSIENT ISCHEMIC ATTACKS (0.72%), 2 DEATHS (0.48%) AND 1 MAJOR STROKE (0.24%). THIS RESULTED IN A CUMULATIVE RATE AT DISCHARGE OF 4.56% ALL STROKES AND DEATHS, AND OF 0.72% MAJOR STROKES AND DEATHS. ALL THE PATIENTS UNDERWENT THIRTY-DAY FOLLOW-UP. AT THIRTY-DAY FOLLOW-UP, THERE WERE NO DEATHS AND NO MINOR AND MAJOR STROKES, CONFIRMING THE OVERALL CUMULATIVE 4.56% INCIDENCE OF ALL STROKES AND DEATHS RATE, AND OF 0.72% RATE OF MAJOR STROKES AND DEATHS AT FOLLOW UP. IN 245 CASES (58.89%) THERE WAS MACROSCOPIC EVIDENCE OF DEBRIS AFTER FILTRATION OF THE ASPIRATED BLOOD. THIS ITALIAN MULTICENTER REGISTRY CONFIRMS AND FURTHER SUPPORTS THE EFFICACY AND APPLICABILITY OF THE ENDOVASCULAR CLAMPING CONCEPT WITH PROXIMAL FLOW BLOCKAGE IN A BROAD PATIENT SERIES. RESULTS MATCH FAVORABLY WITH CURRENT AVAILABLE STUDIES ON CAROTID STENTING WITH CEREBRAL PROTECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433830 MO.MA CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR