BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 12373661 · Received August 26, 2021

    Report

    Report Number
    2029214-2021-01073
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    December 1, 2016
    Report Date
    August 26, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    YE, Z., LV, X. THE FORMATION MECHANISM OF ACUTE DISSECTION OF BLOOD BLISTER-LIKE ANEURYSM AND ITS IMPLICATION OF ENDOVASCULAR TREATMENT. CHINESE NEUROSURGICAL JOURNAL (2021). HTTPS://DOI.ORG/10.1186/S41016-021-00245-1. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. REFER TO MANUFACTURER REPORT 2029214-2021-01072 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    YE, Z., LV, X. THE FORMATION MECHANISM OF ACUTE DISSECTION OF BLOOD BLISTER-LIKE ANEURYSM AND ITS IMPLICATION OF ENDOVASCULAR TREATMENT. CHINESE NEUROSURGICAL JOURNAL (2021). HTTPS://DOI.ORG/10.1186/S41016-021-00245-1. MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF PATIENT COMPLICATIONS IN ASSOCIATION WITH THE USE OF AN ECHELON MICROCATHETER IN PROXIMITY TO THE INTRACRANIAL ANEURYSM AND DEPLOY A STENT (NON-MEDTRONIC) ACROSS THE ENTRY POINT INTO THE BLOOD BLISTER-LIKE ANEURYSMS (BBLA) TO THE EFFECT OF JAILING THE PRECEDING PLACED MICROCATHETER. A FEW PATIENTS UNDERWENT SUCCESSIVE SEQUENTIAL PLACEMENT OF A PIPELINE FLOW-DIVERTING STENT ACROSS THE INTERNAL OSTIUM OF THE BBLA VIA A TRIAXIAL GUIDING CATHETER INCLUDING A 6-FR INTERMEDIATE NAVIEN CATHETER AND A 0.027-IN. MARKSMAN MICROCATHETER AND ADJUNCTIVE COILING. ¿FOLLOW-UP ANGIOGRAPHY CONDUCTED 3 TO 8 MONTHS SUCCESSIVE TO TREATMENT DEMONSTRATED COMPLETE ANEURYSMAL OBLITERATION IN ALL PATIENTS.¿ THE PURPOSE OF THIS ARTICLE WAS TO DEVELOP A MORE INTIMATE AND NUANCED UNDERSTANDING OF THE MECHANISMS UNDERLYING THE PATHOGENESIS OF SOI-DISANT BBLA. 8 CONSECUTIVE PATIENTS HARBORING BBLA UNDERGOING ENDOVASCULAR TREATMENT OF BEIJING TSINGHUA CHANGGUNG HOSPITAL OF TSINGHUA UNIVERSITY WERE SUBJECTED TO THIS RETROSPECTIVE REVIEW. OF THE EIGHT PATIENTS, THE AVERAGE AGE WAS 49 YEARS, FIVE WERE FEMALE. THE FOLLOWING POST-PROCEDURAL OUTCOMES WERE NOTED: RE-BLEEDING SUCCESSIVE TO A CLOSED-CELL STENT ACROSS THE ANEURYSMAL NECK, NON-OCCULT HYDROSTATIC HYDROCEPHALUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268842 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention