BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE VANTAGE WITH SHIELD TECHNOLOGY

    MDR report key: 19271552 · Received May 8, 2024

    Report

    Report Number
    2029214-2024-00877
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    November 19, 2021
    Report Date
    May 8, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT THE PATIENT EXPERIENCED DISORIENTATION, AT TIMES THE PATIENT SEEMS DISORIENTED ALTHOUGH COLLABORATIVE, ONSET DATE OF 2021-11-19. THIS WAS ASSESSED AS POSSIBLE RELATED TO THE STUDY PROCEDURE. THE SPONSOR ASSESSED THIS EVENT AS POSSIBLE RELATED TO THE INDEX PROCEDURE AND DEVICE VANTAGE, NOT RELATED TO ANCILLARY DEVICE OR DUAL ANTIPLATELET THERAPY (DAPT). THE PATIENT ALSO EXPERIENCED PSYCHOMOTOR AGITATION WITH AN ONSET DATE OF 2021-11-19 WHICH RESULTED IN PROLONGATION OF EXISTING HOSPITALIZATION AND CONCOMITANT OR ADDITIONAL TREATMENT BEING GIVEN. PSYCHOMOTOR AGITATION WITH POOR RESPONSE TO HALOPERIDOL IN INCREASING DOSES. DEXMEDETOMIDINE WAS PRESCRIBED WITH GOOD RESPONSE. NO NEUROLOGICAL DEFICIT. THE SITE ASSESSED THIS AS CAUSALLY RELATED TO THE PROCEDURE. THE SPONSOR ASSESSED THIS AS POSSIBLE RELATED TO THE INDEX PROCEDURE, DEVICE VANTAGE, NOT RELATED TO ANCILLARY DEVICE OR DAPT. NEITHER THE DISORIENTATION OR PSYCHOMOTOR AGITATION LED TO CONGENITAL ANOMALY, DEATH, DISABILITY, OR MEDICAL INTERVENTION AND WERE NOT CONSIDERED LIFE-THREATENING. BOTH ISSUES RESOLVED AND THE PATIENT RECOVERED ON 2021-11-29. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, RIGHT INTERNAL CAROTID ARTERY (ICA) C4 SIDEWALL ANEURYSM WITH A MAX DIAMETER OF 20MM AND A 8MM NECK DIAMETER. THE ANEURYSM DOME HEIGHT WAS 18MM AND THE ANEURYSM DOME WIDTH WAS 20MM.  THE PARENT ARTERY DIAMETER DISTAL TO THE ANEURYSM WAS 4.5MM, AND PROXIMAL 5.5MM. THERE WAS SIGNIFICANT STASIS POST PROCEDURE. THERE WAS COMPLETE NECK COVERAGE AT THE END OF THE PROCEDURE. ANEURYSM OCCLUSION (RAYMOND AND ROY) AT THE END OF THE PROCEDURE WAS CLASS 3. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT RESULTED IN NEW OR WORSENING OF EXISTING NEUROLOGICAL DEFICITS AND SYMPTOMS LASTED FOR MORE THAN 24 HOURS. PER SOURCE, THE SUBJECT EXPERIENCED 2 EPISODES OF VOMITING COINCIDING WITH ADMINISTRATION OF CLOPIDOGREL, SUGGESTING IT MAY BE DAPT THERAPY RELATED. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CLINICAL EVENTS COMMITTEE (CEC) ADJUDICATED THE EVENT AS CAUSAL TO THE INDEX PROCEDURE, NOT RELATED TO THE DEVICE VANTAGE OR DAPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752704 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED3-027-600-40 B210778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization