BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 16619954 · Received March 27, 2023

    Report

    Report Number
    2029214-2023-00537
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    February 12, 2013
    Report Date
    March 27, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CHALOUHI N, TJOUMAKARIS S, DUMONT AS, ET AL. TREATMENT OF POSTERIOR CIRCULATION ANEURYSMS WITH THE PIPELINE EMBOLIZATION DEVICE. NEU ROSURGERY. 2013;72(6):883-889. DOI:10.1227/NEU.0B013E31828BA984. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CHALOUHI N, TJOUMAKARIS S, DUMONT AS, ET AL. TREATMENT OF POSTERIOR CIRCULATION ANEURYSMS WITH THE PIPELINE EMBOLIZATION DEVICE. NEU ROSURGERY. 2013;72(6):883-889. DOI:10.1227/NEU.0B013E31828BA984. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH A PIPELINE STENT AND AXIUM COIL. THE PURPOSE OF THIS ARTICLE WAS TO PRESENT THEIR EXPERIENCE WITH USE OF THE PIPELINE EMBOLIZATION DEVICE (PED) IN THE POSTERIOR CIRCULATION. A TOTAL OF 7 PATIENTS HARBORING 7 POSTERIOR CIRCULATION ANEURYSMS WERE TREATED WITH THE PED. THERE WERE 4 WOMEN AND 3 MEN, AND THE MEAN AGE WAS 63 YEARS. A SINGLE STENT WAS USED IN 4 PATIENTS, 2 STENTS IN 2 PATIENTS, AND 3 STENTS IN 1 PATIENT. TREATMENT WAS SUCCESSFUL IN ALL 7 PATIENTS. NO PROCEDURAL OR PERIOPERATIVE COMPLICATIONS OR PERFORATOR INFARCTS WERE NOTED IN THE SERIES. NO PATIENT EXPERIENCED NEW NEUROLOGICAL SYMPTOMS RELATED TO PED TREATMENT DURING THE FOLLOW-UP PERIOD. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED:  - IN ONE PATIENT, A PED WAS PLACED FOLLOWED BY 2 AXIUM COILS. THE PROCEDURE WAS UNEVENTFUL, AND THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. ONE MONTH LATER, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT REPORTING WORSENING BILATERAL HEADACHES. COMPUTED TOMOGRAPHY AND MAGNETIC RESONANCE IMAGING SCANS SHOWED NO EVIDENCE OF INTRACRANIAL HEMORRHAGE OR INFARCTS, AND CEREBRAL ANGIOGRAPHY SHOWED 100% OCCLUSION OF THE ANEURYSM WITH PATENCY OF ALL VESSELS. THE PATIENT¿S HEADACHES SIGNIFICANTLY IMPROVED WITH STEROID THERAPY. FOLLOW-UP ANGIOGRAPHY 3 MONTHS LATER SHOWED PERSISTENCE OF ANEURYSM OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739146 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention