BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 10973375 · Received December 9, 2020

    Report

    Report Number
    2029214-2020-01261
    Event Type
    Injury
    Date Received
    December 9, 2020
    Date of Event
    July 7, 2020
    Report Date
    December 8, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018.S011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MOUBARK, M., ALLAH, A.EK.A., YOSEF, H. ET AL. FLOW DIVERTER DEVICES IN THE TREATMENT OF POSTERIOR COMMUNICATING ARTERY ANEURYSMS: MID-TERM CLINICAL AND RADIOLOGICAL OUTCOMES. EGYPT J RADIOL NUCL MED 51, 118 (2020). HTTPS://DOI.ORG/10.1186/S43055-020-00241-Y. PATIENT AGE: 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. EVENT DATE: 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MOUBARK, M., ALLAH, A.EK.A., YOSEF, H. ET AL. FLOW DIVERTER DEVICES IN THE TREATMENT OF POSTERIOR COMMUNICATING ARTERY ANEURYSMS: MID-TERM CLINICAL AND RADIOLOGICAL OUTCOMES. EGYPT J RADIOL NUCL MED 51, 118 (2020). HTTPS://DOI.ORG/10.1186/S43055-020-00241-Y MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF PATIENT COMPLICATIONS IN ASSOCIATION WITH TREATMENT OF POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSMS BY FLOW DIVERTER (FD) DEVICES. THE PURPOSE OF THIS ARTICLE WAS TO ASSESS THE PIPELINE ANGIOGRAPHIC EFFICACY (COMPLETE ANEURYSM OCCLUSION) AND RELATED COMPLICATIONS. THE AUTHORS REVIEWED 47 CASES OF PATIENTS TREATED FOR PCOM ANEURYSMS USING A PIPELINE FLOW DIVERTER STENT. OF THE 47 PATIENTS, THE AVERAGE AGE WAS 51 YEARS, 40 WERE FEMALE AND 7 WERE MALE. PROCEDURE-RELATED COMPLICATIONS OCCURRED IN FIVE (10.6%) PATIENTS (TWO ISCHEMIC EVENTS, TWO TRANSIENT ISCHEMIC ATTACK (TIA), AND ONE IPSILATERAL DISTAL HEMORRHAGE) AND RESULTED IN PERSISTENT NEUROLOGICAL MORBIDITY IN TWO (4.2%) PATIENTS. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: 1. HEMORRHAGIC COMPLICATIONS OCCURRED IN ONE PATIENT WHO DEVELOPED IPSILATERAL DISTAL HEMORRHAGE <(><<)> 24 H AFTER THE PROCEDURE, AND THE LAST MODIFIED RANKIN SCALE (MRS) SCORE OF 2. 2. ISCHEMIC COMPLICATIONS OCCURRED IN TWO PATIENTS. ONE PATIENT WITH LARGE SIZED ANEURYSM (19.5 MM) WAS TREATED WITH TWO PED STENTS WHICH OCCLUDED 6 MONTHS AFTER PRIMARY TREATMENT WITH AN IPSILATERAL INFRACTION; THE PATIENT DEVELOPED CONTRALATERAL HEMIPLEGIA WITH LAST MRS 3. ANOTHER PATIENT SUFFERED FROM ISCHEMIC COMPLICATIONS SECONDARY TO AN INTRA-PROCEDURE EVENT IN TERMS OF A FAILURE OF PROPER RELEASE OF PED STENT IN THE TREATMENT OF A SMALL-SIZED (9 MM) ANEURYSM WITH IPSILATERAL ICA OCCLUSION AND IMMEDIATE POST-OPERATIVE HEMIPLEGIA WITH LAST MRS 3. 3. TRANSIENT ISCHEMIC ATTACKS OCCURRED IN TWO PATIENTS. ONE PATIENT HARBORING GIANT ANEURYSM TREATED BY TWO PED STENTS WITH ADJUVANT COILING DEVELOPED TRANSIENT CONTRALATERAL HEMIPLEGIA 1 MONTH AFTER TREATMENT WHICH COMPLETELY RESOLVED WITH LAST MRS 0. ANOTHER PATIENT WITH LARGE SIZED ANEURYSM 13.8MM TREATED BY SINGLE PED STENT WITH LAST MRS 0. 4. RETREATMENT WAS NECESSARY FOR TWO UN-OCCLUDED ANEURYSMS THAT WERE RETREATED AT 6TH AND 12TH MONTHS AFTER THE PRIMARY TREATMENT RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444632 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention