BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMENCI PETIT

    MDR report key: 15111634 · Received July 27, 2022

    Report

    Report Number
    3015531723-2022-00012
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    July 13, 2022
    Report Date
    July 27, 2022
    Manufacturer
    RAPID MEDICAL LTD.
    Product Code
    PUU
    UDI-DI
    07290015107044
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COMANECI PETIT WAS USED AS COIL ASSIST DEVICE TO TREAT MCA BIFURCATION ANEURYSM. AFTER THE COILING HAD FINISHED, THE PHYSICIAN CLOSED THE COMANECI PETIT AND NOTICED SOME MOVEMENT OF THE COIL MASS. THE COMANECI COULD BE RETRIEVED, BUT THIS LED TO DISTENSION OF 2 LOOPS OF COIL AND FURTHER DISPLACEMENT OF THE WHOLE COIL MASS WITHIN THE MCA BIFURCATION. SUBSEQUENTLY, THE MIDDLE CEREBRAL ARTERY WAS OCCLUDED. THERE WERE MODERATE ANASTOMOSIS FROM THE ANTERIOR CEREBRAL ARTERY TO THE OCCLUDED MIDDLE CEREBRAL ARTERY. THEREFORE, THE PATIENT WAS IMMEDIATELY TRANSFERRED TO THE OPEN NEUROSURGERY OPERATING ROOM WHERE THE COIL MASS WAS REMOVED BY OPENING THE FUNDUS OF THE ANEURYSM. THE ANEURYSM WAS THEN CLIPPED. FURTHER REPAIR OF THE M1 SEGMENT WAS REQUIRED WITH A SUTURE AND A CLIP PARALLEL TO THE AXIS OF THE M1 SEGMENT DUE TO ONGOING BLEEDING IN THIS PATIENT TREATED BY ASPIRIN AND PRASUGREL IN CASE OF POTENTIAL STENTING. AT THE END OF THE NEUROSURGICAL PROCEDURE, THE MCA APPEARED TO BE OCCLUDED DESPITE NUMEROUS CAUTIONS TO KEEP THIS ARTERY PATENT. THE PATIENT WAS AGAIN TRANSFERRED TO THE CATHLAB TO ATTEMPT A RECANALIZATION PROCEDURE AFTER CLIPPING. ACCESS TO THE M1 SEGMENT DISTAL TO THE FIRST CLIP WAS POSSIBLE WITH A MICROCATHETER. INJECTION THROUGH THE MICROCATHETER AT THE LEVEL OF THE ANEURYSM SHOWED THAT THE ANEURYSM WAS MOSTLY CLIPPED BUT ALSO THE INFERIOR DIVISION BRANCH. THE SUPERIOR DIVISION BRANCH WAS FAINTLY VISIBLE WITHOUT SPONTANEOUS FLOW. SELECTIVE ACCESS TO THIS BRANCH WAS POSSIBLE WITH THE MICROCATHETER, ALLOWING FURTHER PLACEMENT OF A STENT AND IN-STENT PTA. AT THE END OF THE PROCEDURE, THE SUPERIOR DIVISION BRANCH WAS PERFUSED NORMALLY AND ANTEGRADELLY. THE INFERIOR DIVISION BRANCH WAS REFILLED VIA CORTICAL ANASTOMOSIS BUT ONLY PARTIALLY AND WITH A DELAY OF SEVERAL SECONDS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722890 COMENCI PETIT COMANECI PETIT PUU RAPID MEDICAL LTD. ANPP3188 200324CP01 07290015107044

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Hospitalization| O| S| R