BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 21003317 · Received December 23, 2024

    Report

    Report Number
    2029214-2024-02422
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    January 23, 2023
    Report Date
    December 23, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID UNK-NV-SOLITAIRE (UNKNOWN); PRODUCT TYPE: EXPLANT DATE N/A G2: CITATION: AUTHORS: ZHANG G, ZHANG R, WEI Y, CHEN R, ZHANG X, LV G, DUAN G, WANG C, YU Y, DAI D, ZHAO R, LI Q, XU Y, HUANG Q, YANG P, ZUO Q, LIU J. COMPARISON OF STAGED-STENT AND STENT-ASSISTED COILING TECHNIQUE FOR RUPTURED SACCULAR WIDE-NECKED INTRACRANIAL ANEURYSMS: SAFETY AND EFFICACY BASED ON A PROPENSITY SCORE-MATCHED COHORT STUDY. FRONT. NEUROL 14:1101859 2023. 10.3389/FNEUR.2023.1101859. 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

    THE LITERATURE REVIEWED FOCUSED ON THE "COMPARISON OF STAGED-STENT AND STENT-ASSISTED COILING TECHNIQUE FOR RUPTURED SACCULAR WIDE-NECKED INTRACRANIAL ANEURYSMS: SAFETY AND EFFICACY BASED ON A PROPENSITY SCORE-MATCHED COHORT STUDY". THE STUDY WAS CONDUCTED OVER A TIME FRAME FROM (B)(6) 2019. MULTIPLE MANUFACTURERS' DEVICES WERE USED IN THE STUDY POPULATION. MEDTRONIC PRODUCTS WERE MENTIONED IN THE STUDY WAS SOLITAIRE STENT. DEATHS OCCURRED IN THE STUDY POPULATION, WITH A TOTAL OF SIX PATIENTS WHO DIED AT DISCHARGE (PAGE 5). THE CAUSES OF DEATH INCLUDED PROCEDURE-RELATED COMPLICATIONS IN THREE CASES, WHICH INVOLVED ONE CASE OF INTRAPROCEDURAL ANEURYSM RUPTURE AND TWO CASES OF POST-PROCEDURAL EARLY REBLEEDING, AND POOR CLINICAL GRADE AT PRESENTATION AND COMORBIDITY IN THREE CASES. THE PATIENT ADVERSE EVENTS REPORTED INCLUDED HEMORRHAGIC COMPLICATIONS SUCH AS INTRAPROCEDURAL RUPTURE, POST-PROCEDURAL EARLY REBLEEDING, AND SURGICAL PROCEDURE-RELATED HEMORRHAGIC EVENTS; ISCHEMIC COMPLICATIONS LIKE INTRAPROCEDURAL THROMBOSIS AND POST-PROCEDURAL THROMBOSIS AND CEREBRAL VASOSPASM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2617873 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention SEE H11...