BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE AB STENT

    MDR report key: 21728750 · Received March 30, 2025

    Report

    Report Number
    2029214-2025-00802
    Event Type
    Death
    Date Received
    March 30, 2025
    Date of Event
    November 3, 2023
    Report Date
    March 30, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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

    ZHANG, J., LONG, L., LI, J., ZHANG, H., YAN, W., ABULIMITI, A., ABULAJIANG, N., LU, Q., NGUYEN, T. N., & CAI, X.; NEURORADIOLOGY; 2024; 66:1021¿1029; IMPACT OF OBESITY-RELATED INDICATORS ON FRST-PASS EFECT IN PATIENTS WITH ISCHEMIC STROKE RECEIVING MECHANICAL THROMBECTOMY; DOI.ORG/10.1007/S00234-024-03350-X LITERATURE WAS REVIEWED REGARDING: "IMPACT OF OBESITY-RELATED INDICATORS ON FIRST-PASS EFFECT IN PATIENTS WITH ISCHEMIC STROKE RECEIVING MECHANICAL THROMBECTOMY." THE OBJECTIVE IS TO EVALUATE OBESITY-RELATED INDICATORS AS POTENTIAL PREDICTORS OF THE FIRST-PASS EFFECT (FPE) IN PATIENTS WITH ACUTE ISCHEMIC STROKE RECEIVING MECHANICAL THROMBECTOMY (MT). THE TIME FRAME OF THIS STUDY WAS: JANUARY 2019 TO DECEMBER 2021. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE STUDY MENTIONS VARIOUS MEDTRONIC THROMBECTOMY DEVICES INCLUDING STENT RETRIEVERS LIKE SOLITAIR FR AND SOLITAIR AB AS WELL AS CONTACT ASPIRATION USING THE REACT 68 CATHETER. DEATHS OCCURRED IN THE STUDY POPULATION. THE STUDY REPORTED A TOTAL OF 2 DEATHS (1.3% OF PATIENTS), WITH ONE DEATH IN THE FPE GROUP (2.1%) AND ONE IN THE NON-FPE GROUP (1.0%). HOWEVER, THE DOCUMENT DOES NOT SPECIFY THE CAUSES OF THESE DEATHS. AMONG PATIENT ADVERSE EVENTS INCLUDED: HIGHER RATES OF SUBARACHNOID HEMORRHAGE (SAH) IN NON-FPE PATIENTS (0% VS. 11.5%, P = 0.018).  NON-FPE PATIENTS HAD A HIGHER RATE OF RESCUE THERAPY (BALLOON ANGIOPLASTY OR STENT IMPLANTATION), (0% VS. 13.5%, P = 0.012).  HEIDELBERG BLEEDING CLASSIFICATION: 3C: 12 (7.9%) TOTAL, WITH 0% IN FPE AND 11.5% IN NON-FPE (P = 0.018). INTRACRANIAL HEMORRHAGE: 70 (46.3%) TOTAL, WITH 23 (48.9%) IN FPE AND 47 (45.2%) IN NON-FPE (P = 0.726).  SYMPTOMATIC INTRACRANIAL HEMORRHAGE: 14 (9.3%) TOTAL, WITH 5 (10.6%) IN FPE AND 9 (8.7%) IN NON-FPE (P = 0.764). ASYMPTOMATIC INTRACRANIAL HEMORRHAGE: 56 (37.1%) TOTAL, WITH 18 (38.3%) IN FPE AND 38 (36.5%) IN NON-FPE (P = 0.857).  CLINICAL OUTCOMES OF INTEREST: NON-FPE PATIENTS HAD A LONGER MEDIAN PROCEDURE TIME (145 MINUTES VS. 101 MINUTES, P < 0.001), A LOWER RATE OF 24-HOUR EARLY NEUROLOGIC IMPROVEMENT (16.3% VS. 31.9%, P = 0.034), AND A HIGHER PROBABILITY OF FUNCTIONAL DECLINE AT DISCHARGE (MRS 4¿5) (57.7% VS. 38.3%, P = 0.035). NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933013 SOLITAIRE AB STENT INTRACRANIAL NEUROVASCULAR STENT NJE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SAB UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Death