BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COIL-HYDRAULIC

    MDR report key: 18441310 · Received January 3, 2024

    Report

    Report Number
    3008114965-2024-00009
    Event Type
    Injury
    Date Received
    January 3, 2024
    Date of Event
    April 6, 2023
    Report Date
    January 3, 2024
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    PMA / PMN Number
    K093973
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: KULHARI A, FOURCAND F, SINGH A, ZACHARATOS H, MEHTA S, KIRMANI JF. RETRIEVAL OF MIGRATED COILS FROM DISTAL CEREBRAL VASCULATURE USING STENT RETRIEVER: A CASE SERIES. CUREUS. 2023 APR 6;15(4):E37213. DOI: 10.7759/CUREUS.37213. PMID: 37159773; PMCID: PMC10163925. SECTION D.4: THE PRODUCT CATALOG AND LOT NUMBERS ARE NOT AVAILABLE / NOT REPORTED. THE UNIQUE IDENTIFIER (UDI) AND EXPIRATION DATE OF THE DEVICE IS NOT KNOWN. SECTION E.1: THE INITIAL REPORTER PHONE IS NOT AVAILABLE. SECTION H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. SINCE THE EVENTS ARE LIFE THREATENING AND REQUIRED INTRAVENOUS MEDICATION AND A SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS. THE EVENT IS REPORTABLE TO THE US FDA. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: KULHARI A, FOURCAND F, SINGH A, ZACHARATOS H, MEHTA S, KIRMANI JF. RETRIEVAL OF MIGRATED COILS FROM DISTAL CEREBRAL VASCULATURE USING STENT RETRIEVER: A CASE SERIES. CUREUS. 2023 APR 6;15(4):E37213. DOI: 10.7759/CUREUS.37213. PMID: 37159773; PMCID: PMC10163925. BACKGROUND AND PURPOSE: THE INCIDENCE OF COIL DISLOCATION DURING AN ENDOVASCULAR EMBOLIZATION OF INTRACRANIAL ANEURYSM IS LOW BUT IT CAN LEAD TO SERIOUS THROMBO-EMBOLIC COMPLICATIONS. THEREFORE, COIL DISPLACEMENT/MIGRATION OFTEN REQUIRES EITHER RETRIEVAL OR FIXATION OF THE ERRANT COIL WITH A STENT. THERE ARE NO STANDARD RECOMMENDED METHODS OF COIL RETRIEVAL. WE PRESENT A SERIES OF THREE CASES IN WHICH OFF-LABEL APPLICATION OF A STENT RETRIEVER ALLOWED SUCCESSFUL RETRIEVAL OF HERNIATED COILS. CERENOVUS DEVICES THAT WERE USED IN THIS STUDY: CASE 1: QTY 3: THREE GALAXY ORBIT COMPLEX XTRASOFT 2MM X 2CM COILS; CASE 2: QTY 1:ONE GALAXY ORBIT COMPLEX XTRASOFT 5MM X 10CM COIL ; CASE 3: QTY 1: ONE GALAXY ORBIT COMPLEX XTRASOFT COIL (5MM X 10CM). NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: QTY UNK: SL 10 MICROCATHETER (STRYKER NEUROVASCULAR, FREMONT, CA, USA); FLOWGATE (STRYKER NEUROVASCULAR, FREMONT, CA, USA). 3MAX INTERMEDIATE CATHETER (PENUMBRA, ALAMEDA, CA, USA), VELOCITY MICROCATHETER (PENUMBRA, ALAMEDA, CA,USA); SYNCHRO 014 (STRYKER NEUROVASCULAR, FREMONT, CA, USA) MICROWIRE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS : CASE 1 : THREE GALAXY ORBIT COMPLEX XTRASOFT 2MM X 2CM COILS (CODMAN NEUROVASCULAR, RAYNHAM, MA, USA) WERE DEPLOYED THROUGH SL 10 MICROCATHETER (STRYKER NEUROVASCULAR, FREMONT, CA, USA) TO EMBOLIZE THE ANEURYSM. DURING THE PLACEMENT OF THE THIRD COIL, THE FIRST TWO COILS DISLODGED FROM THE ANEURYSM AND MIGRATED INTO THE A2 SEGMENT OF THE LEFT ANTERIOR CEREBRAL ARTERY (ACA). EPTIFIBATIDE BOLUS WAS ADMINISTERED IMMEDIATELY. COIL RETRIEVAL WITH A STENT RETRIEVER (SOLITAIRE 4 X 40 (MEDTRONIC). CASE 2: ONE GALAXY ORBIT COMPLEX XTRASOFT 2.5MM X 3.5CM COIL (CODMAN NEUROVASCULAR, RAYNHAM, MA, USA) WAS DEPLOYED THROUGH THE SL 10 MICROCATHETER (STRYKER NEUROVASCULAR, FREMONT, CA, USA) TO EMBOLIZE THE ANEURYSM (FIGURE 2B). FOLLOW UP ANGIOGRAM SHOWED DISLOCATED COIL MASS IN LEFT PCA (P2-P3 JUNCTION) (FIGURE 2C). EPTIFIBATIDE BOLUS WAS ADMINISTERED IMMEDIATELY. COIL RETRIEVAL WITH A STENT RETRIEVER (SOLITAIRE 4 X 40 (MEDTRONIC). CASE 3: ONE GALAXY ORBIT COMPLEX XTRASOFT 5MM X 10CM COIL (CODMAN NEUROVASCULAR, RAYNHAM, MA, USA) WAS DEPLOYED THROUGH THE SL 10 MICROCATHETER (STRYKER NEUROVASCULAR, FREMONT, CA, USA) TO EMBOLIZE THE ANEURYSM (FIGURE 3B). FOLLOW UP ANGIOGRAM SHOWED DISLOCATED COIL MASS IN THE DISTAL M1 SEGMENT OF RIGHT MCA (FIGURE 3C) . COIL RETRIEVAL WITH A STENT RETRIEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586222 COIL-HYDRAULIC NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R 3MAX INTERMEDIATE CATHETER (PENUMBRA).| FLOWGATE (STRYKER NEUROVASCULAR).| SL 10 MICROCATHETER (STRYKER NEUROVASCULAR).| SYNCHRO 014 (STRYKER NEUROVASCULAR).| VELOCITY MICROCATHETER (PENUMBRA).