BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 20365119 · Received October 3, 2024

    Report

    Report Number
    2029214-2024-01773
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    March 12, 2023
    Report Date
    October 3, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEE ATTACHMENTS FOR LITERATURE ARTICLE. 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

    D. MANTILLA, D. VERA, A. F. ORTIZ, L. PIERGALLINI, J. J. LARA, F. NICOUD, O. VARGAS, V. COSTALAT; WORLD NEUROSURGERY; 2024; 185: E11 99-E1206; OPTIMIZING PATIENT CARE: A MULTICENTRIC STUDY ON THE CLINICAL IMPACT OF SIM SIZE SIMULATION SOFTWARE IN INTRACRANIAL ANEURYSM TREATMENT WITH PIPELINE EMBOLIZATION DEVICES; DOI.ORG/10.1016/J.WNEU.2024.03.052. LITERATURE WAS REVIEWED REGARDING: "OPTIMIZING PATIENT CARE: A MULTICENTRIC STUDY ON THE CLINICAL IMPACT OF SIM SIZE® SIMULATION SOFTWARE IN INTRACRANIAL ANEURYSM TREATMENT WITH PIPELINE EMBOLIZATION DEVICES." THE TIME FRAME OF THIS STUDY WAS: FROM JANUARY 1, 2015, TO DECEMBER 31, 2017, AT THE CHU DE MONTPELLIER, AND FROM JUNE 1, 2014, TO DECEMBER 31, 2019, AT THE FOSCAL CLINIC. THE FOLLOWING MEDTRONIC DEVICES WERE USED: PIPELINE EMBOLIZATION DEVICES (PED), INCLUDING PED FLEX AND PED FLEX WITH SHIELD. NAIVEN 6FR INTERMEDIATE CATHETER. MARKSMAN CATHETER. NO DEATHS WERE REPORTED BEYOND THE 30-DAY POST-PROCEDURE PERIOD. AMONG PATIENT ADVERSE EVENTS INCLUDED: COMPLICATIONS (GENERAL) TOTAL OF 16 COMPLICATIONS: 7 IN THE SIM SIZE® SIMULATION GROUP AND 9 IN THE NON-SIMULATION GROUP. NO MORTALITY OBSERVED BEYOND THE 30-DAY POST-PROCEDURE PERIOD. SPECIFIC COMPLICATIONS: INTRACRANIAL HEMORRHAGIC COMPLICATIONS: THREE CASES IN THE NON-SIMULATION GROUP. ONE DUE TO ANEURYSM RUPTURE DURING A COILING PROCEDURE. TWO POST-SURGERY INTRAPARENCHYMAL HEMORRHAGES. INTRAPARENCHYMAL HEMATOMA: TWO MINOR CASES IN THE NON-SIMULATION GROUP. POST-OPERATIVE SUBARACHNOID HEMORRHAGE: ONE CASE IN THE NON-SIMULATION GROUP. STENT-RELATED COMPLICATIONS: FOUR CASES IN THE SIM SIZE® GROUP, INCLUDING STROKE OCCLUSION AND ARTERY DISSECTION. THREE OF THESE COMPLICATIONS INCLUDED A PARTIAL EMBOLIC OCCLUSION IN THE RIGHT CENTRAL SULCUS ARTERY (ROLANDIC ARTERY), RESULTING IN A PARTIALLY RESOLVED HEMIPARESIS, A MINOR STROKE WITH A TRANSIENT LEG DEFICIT, AND AN ASYMPTOMATIC INTERNAL CAROTID ARTERY DISSECTION. THROMBOEMBOLIC EVENTS: TWO CASES IN THE NON-SIMULATION GROUP. FOUR CASES IN THE SIMULATION GROUP. FEMORAL ACCESS-RELATED HEMORRHAGE: THREE CASES IN THE SIMULATION GROUP. ONE CASE IN THE NON-SIMULATION GROUP. OTHER CLINICAL OUTCOMES OF INTEREST: SHORTER STENTS AND FEWER STENTS REQUIRED IN THE SIMULATION GROUP. BALLOON ANGIOPLASTY MORE COMMON IN THE SIMULATION GROUP (15.3% VS. 4.6%). TWO STENT USED FOR INSUFFICIENT NECK COVERAGE FOR 10 PATIENTS ALL COMPLICATIONS WERE RESOLVED WITHOUT SEQUELAE. THE EXCEPTION WAS THE PARTIAL EMBOLIC OCCLUSION, IN WHICH LEG WEAKNESS PERSISTED AFTER DISCHARGE NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693480 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 57 YR Female