BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 12566101 · Received October 1, 2021

    Report

    Report Number
    1226348-2021-00067
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    June 3, 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 · 0

    (B)(4). LITERATURE ARTICLE: ¿THE FORMATION MECHANISM OF ACUTE DISSECTION OF BLOOD BLISTER-LIKE ANEURYSM AND ITS IMPLICATION OF ENDOVASCULAR TREATMENT¿ YE Z, LV X. CHIN NEUROSURG J. 2021 JUN 3;7(1):32. DOI: 10.1186/S41016-021-00245-1. PMID: 34078466; PMCID: PMC8173849. 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 · 0

    LITERATURE ARTICLE: ¿THE FORMATION MECHANISM OF ACUTE DISSECTION OF BLOOD BLISTER-LIKE ANEURYSM AND ITS IMPLICATION OF ENDOVASCULAR TREATMENT¿ YE Z, LV X. CHIN NEUROSURG J. 2021 JUN 3;7(1):32. DOI: 10.1186/S41016-021-00245-1. PMID: 34078466; PMCID: PMC8173849. OBJECTIVE AND METHODS: FROM DECEMBER 2016 TO DECEMBER 2018, 8 PATIENTS PRESENTING WITH SUBARACHNOID HEMORRHAGE DUE TO BBLA WERE SUBJECTED TO ENDOVASCULAR TREATMENT WITH STENT-ASSISTED COILING. CLINICAL OUTCOMES WERE EVALUATED USING A CLINICAL OUTCOME SCORE SCALE. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: CLOSED-CELL STENT ENTERPRISE, CODMAN OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: 6-FR GUIDING CATHETER ENVOY, CODMAN 8-FR GUIDING CATHETER ENVOY, CORDIS NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: MICROCATHETER ECHELON 10, MEDTRONIC PIPELINE FLOW-DIVERTING STENT, MEDTRONIC 6-FR INTERMEDIATE CATHETER NAVIEN, MEDTRONIC MICROCATHETER MARKSMAN, MEDTRONIC ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: (B)(6) MALE WITH ENTERPRISE STENT EXPERIENCED POSTOPERATIVE REGROWTH AND RE-BLEEDING. TREATMENT OR INTERVENTION NOT DESCRIBED WITHIN THE ARTICLE. FOLLOW-UP ANGIOGRAPHY CONDUCTED 3 TO 8 MONTHS SUCCESSIVE TO PROCEDURE DEMONSTRATED COMPLETE ANEURYSMAL OBLITERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461853 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening 6-FR GUIDING CATHETER ENVOY, CODMAN| 6-FR INTERMEDIATE CATHETER NAVIEN, MEDTRONIC| 8-FR GUIDING CATHETER ENVOY, CORDIS| MICROCATHETER ECHELON 10, MEDTRONIC| MICROCATHETER MARKSMAN, MEDTRONIC| PIPELINE FLOW-DIVERTING STENT, MEDTRONIC