BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 19183289 · Received April 25, 2024

    Report

    Report Number
    2029214-2024-00750
    Event Type
    Injury
    Date Received
    April 25, 2024
    Date of Event
    August 4, 2023
    Report Date
    April 25, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2. REPORTED AGE (55 YEARS) IS THE MEAN AGE OF ALL PATIENT INCLUDED IN THE STUDY. A3A. REPORTED SEX (MALE) IS REPRESENTATIVE OF THE MAJORITY OF PATIENT INCLUDED IN THE STUDY. 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

    JIN, H., LV, J., MENG, X., LIU, X., HE, H., <(>&<)> LI, Y. (2023). PIPELINE VERSUS TUBRIDGE IN THE TREATMENT OF UNRUPTURED POSTERIOR CIRCULATION ANEURYSMS. CHINESE NEUROSURGICAL JOURNAL, 9(1). HTTPS://DOI.ORG/10.1186/S41016-023-00337-0 MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A RETROSPECTIVE STUDY COMPARING THE SAFETY AND CLINICAL EFFICACY OF THE PIPELINE EMBOLIZATION DEVICE (PED) AND NON-MEDTRONIC TUBRIDGE FLOW DIVERTER (TFD) FOR THE TREATMENT OF UNRUPTURED POSTERIOR CIRCULATION ANEURYSMS, WHICH IS OFF-LABEL USE FOR OF THE PED. IT WAS NOTED THAT A TOTAL OF 115 FLOW DIVERTERS WERE USED TO TREAT 107 ANEURYSMS. 55 PATIENTS WERE TREATED WITH PEDS. IT WAS NOTED THAT ALL FLOW DIVERTERS WERE SUCCESSFUL IMPLANTED WITH A 100% TECHNICAL SUCCESS RATE; NO DEVICE MALFUNCTION WAS REPORTED IN THE LITERATURE ARTICLE. A TOTAL OF 9 PATIENTS IN THE STUDY GROUP HAD PROCEDURE-RELATED POST-INTERVENTION ISCHEMIC COMPLICATIONS, 4 OF THESE PATIENTS WERE TR EATED WITH PED. THOUGH THE ADVERSE EVENTS WERE FURTHER DESCRIBED IN THE ARTICLE, IT WAS NOT SPECIFIED WHICH EVENTS PERTAINED TO PATIENTS TREATED WITH PED VERSUS PATIENTS TREATED WITH TFD. THE FOLLOWING ADVERSE EVENTS WERE NOTED: THREE PATIENTS EXPERIENCED TRANSIENT ISCHEMIC SYMPTOMS: ONE WITH UNILATERAL LIMB NUMBNESS, ONE WITH UNILATERAL LIMB NUMBNESS AND DIP LOPIA, AND ONE EXPERIENCED CORTICAL BLINDNESS. COMPUTED TOMOGRAPHY (CT) OR MAGNETIC RESONANCE IMAGING (MRI) REVEALED NO INFARCTION. ALL THREE PATIENTS TOTALLY RECOVERED BY DISCHARGED AFTER TREATMENT WITH ANTI-VASOSPASM AND IV TIROFIBAN MEDICATION. FOUR PATIENTS SUFFERED NEUROLOGIC DEFICIT RANGING FROM MILD TO SEVERE. ASSOCIATED SYMPTOMS INCLUDED: HEMIPARESIS, DYSARTHRIA, DYSPHAGIA, AND/OR VERTIGO. CT OR MRI CONFIRMED BRAIN STEM OR CEREBELLUM INFARCTION. INTRA-STENT THROMBOSIS OR PERFORATOR OCCLUSION WAS POTENTIAL CAUSE. TIROFIBAN, VOLUME EXPANSION, ANTI-VASOSPASM TREATMENT, AND AGENT-PROMOTING COLLATERAL CIRCULATION WERE USED TO ADDRESS. PHYSICAL REHABILITATION WAS RECOMMENDED AT DISCHARGE. ASIDE FROM THE PATIENT WHO DIED, ONE OTHER PATIENT EXPERIENCED MASS EFFECT. IT WAS NOTED THAT THIS PATIENT HAD BEEN TREATED FOR A 26MM GIANT ANEURYSM. THE EVENT PRESENTED AS LOSS OF CONSCIOUSNESS, DYSARTHRIA, AND RIGHT LIMB WEAKNESS 1 DAYS POST-OPERATIVE. THE PATIENT GRADUALLY RECOVERED AFTER MEDICAL TREATMENT USING MANNITOL AND GLUCOCORTICOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615696 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 55 YR Male Required Intervention| O