BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVIEN CATHETER

    MDR report key: 21566975 · Received March 10, 2025

    Report

    Report Number
    2029214-2025-00613
    Event Type
    Death
    Date Received
    March 10, 2025
    Date of Event
    September 5, 2024
    Report Date
    March 10, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID UNK-NV-RFX (UNKNOWN); PRODUCT TYPE: IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: VASCONCELLOS DE OLIVEIRA SOUZA, N., BENALIA, V. H., ORTEGA MORENO, D. A., LIU, E., CHAN, V., BHARATHA, A., MAROTTA, T. R., SPEARS, J., PEREIRA, V. M. SILK VISTA BABY FLOW DIVERSION BEYOND THE CIRCLE OF WILLIS: A SINGLE-CENTER EXPERIENCE WITH LONG-TERM OUTCOMES. INTERVENTIONAL NEURORADIOLOGY¿: JOURNAL OF PERITHERAPEUTIC N 30(6):846-853 2024. DOI:10.1177/15910199241285504 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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

    LITERATURE WAS REVIEWED REGARDING: THE USE OF FLOW DIVERTERS (FDS) FOR TREATING ANEURYSMS BEYOND THE CIRCLE OF WILLIS, EMPHASIZING A LACK OF EVIDENCE ON THEIR SAFETY AND EFFECTIVENESS IN SUCH CASES. THE SILK VISTA BABY (SVB) FD HAS BEEN USED FOR UNRUPTURED, LARGE, AND COMPLEX ANEURYSMS, BUT DATA ON LONG-TERM OUTCOMES FOR BIFURCATION AND BEYOND THE CIRCLE OF WILLIS ANEURYSMS IS LIMITED. (PAGES 846-847) THE TIME FRAME OF THIS STUDY WAS: OCTOBER 2018 TO DECEMBER 2022. (PAGE 848) MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION.: DEVICES FROM MULTIPLE MANUFACTURERS WERE UTILIZED, INCLUDING THE SILK VISTA BABY (SVB) FD FROM BALT, AND OTHER DEVICES FROM PENUMBRA INC. AND MICROVENTION-TERUMO. (PAGE 848) THE FOLLOWING MEDTRONIC DEVICES WERE USED: NAVIEN 058 CATHETER. IT WAS NOT STATED HOW MANY PROCEDURES USED A NAVIEN CATHETER. (PAGE 848) DEATHS OCCURRED IN THE STUDY POPULATION.: THERE WAS ONE DEATH DUE TO COMPLICATIONS FROM SUBARACHNOID HEMORRHAGE (SAH). (PAGE 849) AMONG PATIENT ADVERSE EVENTS INCLUDED: - INTRAPROCEDURAL COMPLICATIONS ACCOUNTED FOR 3 (5.3%) WHERE ONE PATIENT HAD A DISSECTING HEMATOMA OF THE RECTUS ABDOMINAL MUSCLE, AND ONE PATIENT HAD A RETROPERITONEAL HEMATOMA, WHICH LED TO CLINICAL INSTABILITY, ULTIMATELY WITH GOOD PATIENT OUTCOME AND DISCHARGE MRS OF 2. THE THIRD PATIENT HAD A DISSECTION OF THE ORIGIN OF THE POSTERIOR INFERIOR CEREBELLAR ANEURYSM (PICA) ARTERY WITH AN ISCHEMIC EVENT ON THE FOLLOW-UP MRI, HOWEVER WITH NO CLINICAL CORRELATION. - THERE WAS 1 COMPLICATION OF ISCHEMIA ARISING FROM IN-STENT THROMBOSIS (1.8%) ON THE THIRD DAY AFTER THE PROCEDURE. THE PATIENT WAS DISCHARGED AND RETURNED WITH HEADACHES, VISUAL SCOTOMAS, AND VOMITING, WITH NO HEMORRHAGE OF ADMISSION PLAIN CT. AN IMMEDIATE CEREBRAL ANGIOGRAM SHOWED AN OCCLUDED PERICALLOSAL STENT; HOWEVER, REVASCULARIZATION WAS NOT ATTEMPTED BECAUSE OF EXCELLENT COLLATERALS AND THE ABSENCE OF MAJOR NEUROLOGICAL SYMPTOMS. THERE WERE ASYMPTOMATIC PUNCTATE DWI-RESTRICTION LESIONS OVER THE RIGHT FRONTAL LOBE, RIGHT CINGULATE GYRUS, AND CORPUS CALLOSUM. THE EPISODE WAS CONSIDERED A SEIZURE BY THE NEUROLOGY TEAM AND THE PATIENT WAS DISCHARGED WITH SEIZURE PROPHYLAXIS. - MINOR COMPLICATIONS ACCOUNTED FOR 3.5% (2/57) (ONE CASE OF ASYMPTOMATIC PICA OCCLUSION WITH GOOD COLLATERALS AND CONSERVATIVE MANAGEMENT), WITH NO HEMORRHAGIC COMPLICATION, AND ONE PRESENTED WITH A LATE TRANSITORY SYMPTOMATIC ISCHEMIA. - ALL PATIENTS DISCHARGED WITH MRS > 2 (3/57, 5.3%) PRESENTED WITH HIGH-GRADE SAH, AND IN-HOSPITAL COMPLICATIONS (DELAYED CEREBRAL ISCHEMIA, AND INFECTIONS). NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032533 NAVIEN CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-RFX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death SEE H11...