BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 12422423 · Received September 3, 2021

    Report

    Report Number
    2029214-2021-01109
    Event Type
    Injury
    Date Received
    September 3, 2021
    Date of Event
    April 25, 2018
    Report Date
    September 3, 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

    WANG T, RICHARD SA, JIAO H, LI J, LIN S, ZHANG C, WANG C, XIE X, YOU C. INSTITUTIONAL EXPERIENCE OF IN-STENT STENOSIS AFTER PIPELINE FLOW DIVERTER IMPLANTATION: A RETROSPECTIVE ANALYSIS OF 6 ISOLATED CASES OUT OF 118 PATIENTS. MEDICINE 2021;100:11(E25149) HTTP://D X.DOI.ORG/10.1097/MD.0000000000025149. AGE OR DATE OF BIRTH: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: 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 2029214-2021-01108 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

    WANG T, RICHARD SA, JIAO H, LI J, LIN S, ZHANG C, WANG C, XIE X, YOU C. INSTITUTIONAL EXPERIENCE OF IN-STENT STENOSIS AFTER PIPELINE FLOW DIVERTER IMPLANTATION: A RETROSPECTIVE ANALYSIS OF 6 ISOLATED CASES OUT OF 118 PATIENTS. MEDICINE 2021;100:11(E25149) HTTP://D X.DOI.ORG/10.1097/MD.0000000000025149. MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF PATIENT COMPLICATIONS IN ASSOCIATION WITH IMPLANTATION OF THE FLEX PIPELINE EMBOLIZATION DEVICE (PLED). WALL MALAPPOSITION WAS OBSERVED IN 2 PATIENTS. THE PURPOSE OF THIS ARTICLE WAS TO IDENTIFY PATIENTS WITH, IN-STENT STENOSIS (ISS) AFTER IMPLANTATIONS OF PIPELINE FLEX EMBOLIZATION DEVICES AS TREATMENTS FOR INTRACRANIAL ANEURYSMS. THEY OBSERVED 5% (6/118) INCIDENCE RATE OF ISS IN INTRACRANIAL ANEURYSMAL PATIENTS TREATED WITH PLEDS AT THE INSTITUTION. THE PATIENTS WERE MADE UP OF 2 MALES AND 4 FEMALES WITH A MEAN AGE OF 42. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: DIZZINESS. BLURRING OF VISION SEVERE STENOSIS. WALL MALAPPOSITION WAS OBSERVED IN 2 PATIENTS, WHICH OCCURRED IN THE DISTAL SEGMENTS OF THE ICAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321702 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK FLEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other