BEUDAMED
    FDA Adverse Event Death Summary report: N

    REBAR

    MDR report key: 14744723 · Received June 20, 2022

    Report

    Report Number
    2029214-2022-01029
    Event Type
    Death
    Date Received
    June 20, 2022
    Date of Event
    December 14, 2020
    Report Date
    June 20, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BORGGREFE, J., GOERTZ, L., ABDULLAYEV, N., HOKAMP, N. G., KOWOLL, C. M., ONUR, Ö., KABBASCH, C., & SCHLAMANN, M. (2021). MECHANICAL THROMBECTOMY WITH THE NOVEL NEVA M1 STENT RETRIEVER: DO THE DROP ZONES REPRESENT A RISK OR A BENEFIT- WORLD NEUROSURGERY, 148. HTTPS://DOI.ORG/10.1016/J.WNEU.2020.12.075. AGE OR DATE OF BIRTH. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    BORGGREFE, J., GOERTZ, L., ABDULLAYEV, N., HOKAMP, N. G., KOWOLL, C. M., ONUR, Ö., KABBASCH, C., & SCHLAMANN, M. (2021). MECHANICAL THROMBECTOMY WITH THE NOVEL NEVA M1 STENT RETRIEVER: DO THE DROP ZONES REPRESENT A RISK OR A BENEFIT- WORLD NEUROSURGERY, 148. HTTPS://DOI.ORG/10.1016/J.WNEU.2020.12.075 SUMMARY: THE NEVA M1 THROMBECTOMY DEVICE IS A NOVEL HYBRID-CELL STENT RETRIEVER WITH MULTIFUNCTIONAL ZONES FOR OPTIMIZED RETRIEVAL OF RESISTANT CLOTS LOCATED IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE OBJECTIVE WAS TO EVALUATE THE SAFETY AND EFFICACY OF THE NEVA IN A ¿REAL-LIFE¿ SETTING. IDENTIFIED EVENTS: 1. THERE WERE 13 PATIENTS THAT DIED. 6 PATIENTS DIED IN-HOSPITAL AND 7 PATIENTS HAD AN ALL-CAUSE MORTALITY . THE STENT RETRIEVERS WERE USED IN COMBINATION WITH A DISTAL ASPIRATION CATHETER (AXS CATALYST 5; STRYKER NEUROVASCULAR, FREMONT, CALIFORNIA, USA) OR A 5F/6F SOFIA CATHETER (MICROVENTION, TUSTIN, CALIFORNIA, USA). THE MICROCATHETERS USED WERE REBAR 18 OR HEADWAY 21. TREVO (STRYKER), SOLITAIRE (MEDTRONIC, IRVINE, CALIFORNIA, USA), APERIO HYBRID (ACANDIS, PFORZHEIM, GERMANY) STENT RETRIEVERS, AND THE JET 7 REPERFUSION CATHETER (PENUMBRA, ALAMEDA, CALIFORNIA, USA) WERE USED FOR RESCUE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2156384 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-REBAR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Death