BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 12566206 · Received October 1, 2021

    Report

    Report Number
    1226348-2021-00070
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    May 21, 2021
    Report Date
    September 6, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). LITERATURE CITATION: ZHANG J, YU M, LV X. ENDOVASCULAR TREATMENT OF BLOOD BLISTER-LIKE ANEURYSMS OF INTERNAL CAROTID ARTERY: STENT-ASSISTED COILING AND PIPELINE FLOW DIVERSION. J CLIN NEUROSCI. 2021 AUG;90:8-13. DOI: 10.1016/J.JOCN.2021.04.040. EPUB 2021 MAY 21. PMID: 34275585. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITE WAS REVIEWED: ZHANG J, YU M, LV X. ENDOVASCULAR TREATMENT OF BLOOD BLISTER-LIKE ANEURYSMS OF INTERNAL CAROTID ARTERY: STENT-ASSISTED COILING AND PIPELINE FLOW DIVERSION. J CLIN NEUROSCI. 2021 AUG;90:8-13. DOI: 10.1016/J.JOCN.2021.04.040. EPUB 2021 MAY 21. PMID: 34275585. OBJECTIVE AND METHODS: TO REPORT THE STENT-ASSISTED COIL EMBOLIZATION AND FLOW DIVERSION TREATMENTS OF BLOOD-BLISTER-LIKE ANEURYSMS BASED ON THE THEORY OF ACUTE DISSECTION OF THE INTERNAL CAROTID ARTERY. FROM JULY 2016 THROUGH JULY 2020, 27 PATIENTS PRESENTING WITH SUBARACHNOID HEMORRHAGE (SAH) DUE TO RUPTURE OF INTERNAL CAROTID ARTERY BLOOD BLISTER-LIKE ANEURYSMS WERE SUBJECTED TO ENDOVASCULAR TREATMENT WITH STENT-ASSISTED COILING OR PIPELINE FLOW DIVERSION. CLINICAL OUTCOMES WERE EVALUATED USING MODIFIED RANKIN SCALE SCORE (MRS). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ENTERPRISE STENT (NOTED TO BE USED ONLY IN CASE #1 IN TABLE 1. OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: 8 FRENCH GUIDING CATHETER (ENVOY). NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: MICROCATHETER (ECHELON 10, MEDTRONIC), STENT (NEUROFORM EZ, STRYKER), PIPELINE FLOW DIVERSION (MEDTRONIC), 6 FRENCH INTERMEDIATE CATHETER (NAVIEN, MEDTRONIC), 0.027-INCH MICROCATHETER (MARKSMAN, MEDTRONIC) COIL MANUFACTURERS WERE NOT IDENTIFIED WITHIN ARTICLE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: 50 YEARS OLD MALE WITH 9 MM ANEURYSM HEIGHT TREATED WITH ENTERIPRISE STENT AND UNKNOWN MANUFACTURER COILS IS NOTED TO HAVE COMPLICATION OF REGROWTH AND REBLEEDING. THE ENTERPRISE STENT PATIENT EXPERIENCED POSTOPERATIVE REBLEEDING AT ONE WEEK HOSPITAL DAY AND THE ANEURYSM WAS RETREATED WITH COILS. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462194 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention