BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVM MICROCLIP PHYNOX CVD.2MM STERILE

    MDR report key: 18425571 · Received January 2, 2024

    Report

    Report Number
    9610612-2023-00283
    Event Type
    Injury
    Date Received
    January 2, 2024
    Date of Event
    December 11, 2023
    Report Date
    March 20, 2024
    Manufacturer
    AESCULAP AG
    Product Code
    HCH
    PMA / PMN Number
    K024349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5 - DESCRIPTION UPDATED. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    UPDATE: AFTER THE DEVICES WERE RECEIVED, LEADING AND INVOLVED COMPONENTS WERE CONFIRMED. THE PHYNOX AVM CLIP APPLIER IS NOW CONSIDERED TO BE THE LEADING MATERIAL, (AESCULAP AG REFERENCE NO. (B)(4)), AND ALL CLIPS ARE INVOLVED COMPONENTS. ASSOCIATED MEDWATCH REPORT: 9610612-2024-00051 (AESCULAP AG REFERENCE NO. (B)(4) + FE908K). INVOLVED COMPONENTS: 9610612-2023-00279 (AESCULAP AG REFERENCE NO. (B)(4) + FE964K). 9610612-2023-00280 (AESCULAP AG REFERENCE NO. (B)(4) + FE964K). 9610612-2023-00281 (AESCULAP AG REFERENCE NO. (B)(4) + FE963K). 9610612-2023-00282 (AESCULAP AG REFERENCE NO. (B)(4) + FE963K). 9610612-2023-00283 (AESCULAP AG REFERENCE NO. (B)(4) + FE962K). 9610612-2023-00284 (AESCULAP AG REFERENCE NO. (B)(4) + FE963K). 9610612-2023-00285 (AESCULAP AG REFERENCE NO. (B)(4) + FE953K).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED: THE PROCEDURE WAS AN OPEN CRANIOTOMY FOR AVM RESECTION. IMPLANTATION OF ANEURYSM CLIPS INSTEAD OF AVM CLIPS WAS PERFORMED. THERE WAS AN ADDITIONAL ESTIMATED ONE (1) HOUR OF ANESTHESIA TIME AND THE NEED FOR ADDITIONAL DISSECTION OF SCAR TISSUE TO IDENTIFY THE APPROPRIATE LOCATION SINCE A CLIP COULD NOT BE USED AS A RADIOGRAPHIC MARKER. THE CURRENT STATUS OF THE PATIENT WAS NOTED AS "DOING WELL". ASSOCIATED MEDWATCH-REPORTS: 9610612-2023-00279 (AESCULAP AG REFERENCE NO. (B)(4) + FE964K). 9610612-2023-00280 (AESCULAP AG REFERENCE NO. (B)(4) + FE964K). 9610612-2023-00281 (AESCULAP AG REFERENCE NO. (B)(4) + FE963K). 9610612-2023-00282 (AESCULAP AG REFERENCE NO. (B)(4) + FE963K). 9610612-2023-00283 (AESCULAP AG REFERENCE NO. (B)(4) + FE962K). 9610612-2023-00284 (AESCULAP AG REFERENCE NO. (B)(4) + FE963K). 9610612-2023-00285 (AESCULAP AG REFERENCE NO. (B)(4) + FE953K). INVOLVED COMPONENT: FE908K / PHYNOX AVM CLIP APP FCPS TUB SHAFT90MM - LOT 2380 (AESCULAP AG REFERENCE NO. (B)(4)).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT FE962K - AVM MICROCLIP PHYNOX CVD.2MM STERILE. ACCORDING TO THE COMPLAINT DESCRIPTION, THE AVM CLIPS STAYED OPEN AFTER BEING LOADED AND PREPARED ON THE APPLIER. FOUR (4) CLIPS WERE INITIALLY ATTEMPTED. THE PATIENT WAS REQUIRED TO RETURN TO THE OPERATING ROOM (OR) AFTER THE INTERVENTIONAL RADIOLOGY (IR) PROCEDURE. THEN, THREE (3) MORE CLIPS WERE TRIED LATER THAT SAME DAY. A REVISION WAS REQUIRED. ADDITIONAL INFORMATION WAS NOT PROVIDED, BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE: (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2023-00279 ((B)(4) + FE964K), 9610612-2023-00280 ((B)(4) + FE964K), 9610612-2023-00281 ((B)(4) + FE963K), 9610612-2023-00282 ((B)(4) + FE963K), 9610612-2023-00284 ((B)(4) + FE963K), 9610612-2023-00285 ((B)(4) + FE953K). INVOLVED COMPONENT: FE908K / PHYNOX AVM CLIP APP FCPS TUB SHAFT90MM - LOT 2380 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723245 AVM MICROCLIP PHYNOX CVD.2MM STERILE CEREBRO VASCULAR CLIPS HCH AESCULAP AG FE962K 52740920

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention FE908K - LOT 2380| FE908K - LOT 2380| FE953K - LOT 52789442| FE962K - LOT 52740920| FE963K - LOT 52651966| FE963K - LOT 52820281| FE963K - LOT 52820281| FE964K - LOT 52678351| FE964K- LOT 52735049