BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMANECI

    MDR report key: 12779170 · Received November 9, 2021

    Report

    Report Number
    3009957947-2021-00007
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    December 25, 2020
    Report Date
    November 9, 2021
    Manufacturer
    RAPID MEDICAL LTD
    Product Code
    PUU
    PMA / PMN Number
    DEN170064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FOLLOWING SUBMISSION OF THE SUCCESS POST MARKET SURVEILLANCE STUDY SEMI-ANNUAL PROGRESS REPORT, THE COMPANY BECAME AWARE THAT A CASE OF A (B)(6) FEMALE THAT WAS TREATED WITH THE COMANECI 17 WAS CHARACTERIZED BY THE STUDY INDEPENDENT DATA SAFETY MONITORING BOARD (DSMB) AS A POSSIBLY DEVICE-RELATED EVENT, AND DEFINITELY RELATED TO THE PROCEDURE OR THE TARGET ANEURYSM. THE PATIENT PRESENTED WITH A HISTORY OF HYPERTENSION AND CEREBROVASCULAR ATTACK (2009). ON (B)(6) 2020, THE PATIENT WAS DIAGNOSED WITH A RUPTURE RIGHT ANTERIOR COMMUNICATING ARTERY ANEURYSM AND SAH ALONG THE COURSE OF ANTERIOR CEREBRAL ARTERIES. THE PATIENT'S CONDITION WAS SEVERE (HUNT AND HESS SCORE 4), AND SHE WAS TRANSFERRED TO A DEDICATED CENTER FOR FURTHER TREATMENT. THE ANEURYSM PROCEDURE WAS PERFORMED ON (B)(6), A COILING ATTEMPT WAS PERFORMED WHILE USING THE COMANECI 17 AS A COILING ASSIST DEVICE, HOWEVER, NO FILLING OF THE IPSILATERAL ACA WAS NOTED AFTER THE RECAPTURE OF THE COMANECI DEVICE. THEREFORE, AN ATLAS STENT WAS PLACED FROM THE RIGHT A1 TO A2 TO BAIL OUT THE CLOSURE OF THE RIGHT ACA RESTORING FLOW TO THE RIGHT ANTERIOR CIRCULATION. AT THE END OF THE PROCEDURE, A SMALL CATHETER-RELATED DISSECTION WAS SEEN IN THE PETROUS SECTION OF THE ICA, WHICH NEARLY HEALED BY THE END OF THE CASE. NO ANEURYSM, ARTERIOVENOUS MALFORMATION, FISTULA, OR CLOT IN THE ANTERIOR CEREBRAL ARTERIES WAS SEEN. COMPLETE RESTORATION OF FLOW TO BOTH ANTERIOR CEREBRAL ARTERIES WAS NOTED AT THE END OF THE CASE. POST-PROCEDURE: INTRACRANIAL PRESSURES ELEVATED OVERNIGHT; CT HEAD SHOWED RIGHT FRONTAL ACA TERRITORY INFARCT CONTINUED LARGE AMOUNT OF DIFFUSE SAH, CONTINUED VENTRICULAR HEMORRHAGE, VENTRICLES MILDLY DECOMPRESSED. VASOSPASM SECONDARY TO SAH WAS NOTED ON (B)(6) AND ONGOING AT THE TIME OF DISCHARGE. VASOSPASM WAS NOT NOTED AT THE 30- DAY FOLLOW-UP. THE SAH AND THE VASOSPASM WERE DETERMINED TO BE RELATED TO THE TARGET ANEURYSM AND NOT THE COMANECI DEVICE, WHILE THE STENOSIS REQUIRING STENTING WAS DETERMINED TO BE POSSIBLY RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678775 COMANECI COMANECI 17 PUU RAPID MEDICAL LTD ANPP7199 201021CS01

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention