BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE

    MDR report key: 9844977 · Received March 17, 2020

    Report

    Report Number
    2029214-2020-00246
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    March 26, 2018
    Report Date
    March 17, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICES WERE NOT RETURNED, WE ARE UNABLE TO PERFORM FURTHER ROOT CAUSE ANALYSIS AND THE EXACT CAUSE OF THE REPORTED EVENT IS UNKNOWN. ALL DEVICES ARE 100% TESTED AND ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. NO CORRECTIVE ACTION. MONITORING AND TRENDING THIS TYPE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CLIN NEURORADIOL. 2019 DEC;29(4):725-731. DOI: 10.1007/S00062-018-0723-Z. EPUB 2018 AUG 30. ¿TREATMENT OF UNRUPTURED, TANDEM ANEURYSMS OF THE ICA WITH A SINGLE FLOW DIVERTER¿ P. BHOGAL, J.CHUDYK, C. BLEISE, I. LYLYK, N. PEREZ, H. HENKES, P. LYLYK MEDTRONIC RECEIVED THE FOLLOWING REPORT THROUGH LITERATURE REVIEW: THERE WERE THREE TECHNICAL COMPLICATIONS WITH INCOMPLETE OPENING OF THE DEVICES REQUIRING BALLOON ANGIOPLASTY AT THE END OF THE PROCEDURE, WHICH OCCURRED WITH THE PIPELINE. THERE WERE THREE CLINICAL COMPLICATIONS. IN ONE PATIENT THERE WAS A LARGE PUNCTURE SITE HEMATOMA AND ONE PATIENT SUFFERED FROM EPISTAXIS SECONDARY TO THE ANTI-PLATELET MEDICATION. IN ONE CASE THE PATIENT STOPPED TAKING THE ANTI-PLATELET MEDICATION AND THIS RESULTED IN OCCLUSION OF THE ICA AND A LARGE HEMISPHERIC INFARCTION AND DEATH. THERE WAS NO ALLEGATION TO WHAT DEVICE WAS USED TO TREAT THESE THREE PATIENTS. A TOTAL OF 69 PATIENTS (62 FEMALE, 89.8%) WITH AVERAGE AGE 55± 14.8 YEARS WERE IDENTIFIED. IN TOTAL THERE WERE 169 ANEURYSMS AND THE MAJORITY OF PATIENTS (N= 47, 68.1%) HAD ONLY 2 TANDEM ANEURYSMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307440 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1