BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMANECI EMBOLIZATION ASSIST DEVICE

    MDR report key: 19641883 · Received July 1, 2024

    Report

    Report Number
    3015531723-2024-00002
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    June 15, 2023
    Report Date
    July 1, 2024
    Manufacturer
    RAPID MEDICAL LTD
    Product Code
    PUU
    UDI-DI
    07290015107136
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINT DESCRIPTION, THERE'S NO INDICATION OF ANY DEVICE MALFUNCTION. EMBOLI FORMATION IS A KNOWN COMPLICATION OF WIDE NECK ANEURYSM EMBOLIZATION TREATMENTS WITH ASSIST DEVICES. NO CORRECTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED IN THE SUCCESS POST-MARKET SURVEILLANCE STUDY INVOLVING A 65-YEAR-OLD MALE WITH A HISTORY OF HYPERTENSION AND MIGRAINES. HE WAS TREATED WITH THE COMANECI AND ATLAS STENT FOR A RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT EXPERIENCED LEFT UPPER EXTREMITY WEAKNESS AND DYSMETRIA, LEADING TO HOSPITAL ADMISSION. AN MRI REVEALED MULTIPLE ACUTE CEREBROVASCULAR ACCIDENT (CVA) AREAS, PREDOMINANTLY IN THE RIGHT BILATERAL WATERSHED DISTRIBUTION. THE PATIENT CONTINUED DUAL ANTIPLATELET THERAPY AND STATIN TREATMENT. NEUROLOGY SUGGESTED A LOOP RECORDER IMPLANT AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) FOR FURTHER EMBOLIC SOURCE EVALUATION. THE PATIENT UNDERWENT LINQ PLACEMENT AND TEE, WHICH SHOWED NO PATHOLOGY TO EXPLAIN THE CVA. CARDIOLOGY RECOMMENDED FOLLOW-UP IN ONE WEEK. THE PATIENT WAS DISCHARGED ON (B)(6) 2023, WITH FOLLOW-UPS SCHEDULED WITH HIS PRIMARY CARE PHYSICIAN AND CARDIOLOGY. THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON JUNE 19, 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2192806 COMANECI EMBOLIZATION ASSIST DEVICE COMANECI PUU RAPID MEDICAL LTD ANPP7177 230212CC01 07290015107136

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention