BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 16273794 · Received January 31, 2023

    Report

    Report Number
    2029214-2023-00140
    Event Type
    Death
    Date Received
    January 31, 2023
    Date of Event
    June 20, 2022
    Report Date
    February 9, 2023
    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

    THIS REPORT PERTAINS TO THE PATIENT DEATH REPORTED IN THE ARTICLE. AS IT WAS NOT INDICATED WHICH DEVICE WAS USED IN THE PROCEDURE, THEREFORE A SEPARATE REPORT WILL BE SUBMITTED FOR A PIPELINE DEVICE. SEPARATE REPORTS WILL BE SUBMITTED FOR SERIOUS INJURIES REPORTED IN THE ARTICLE. 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.

    Additional Manufacturer Narrative · 0

    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

    WU, Q., LI, T., JIANG, W., HERNESNIEMI, J. A., LI, L., <(>&<)> HE, Y. (2022). CONSERVATIVE THERAPY VS. ENDOVASCULAR APPROACH FOR INTRACRANIAL VERTEBROBASILAR ARTERY TRUNK LARGE ANEURYSMS: A PROSPECTIVE MULTICENTER COHORT STUDY. OXIDATIVE MEDICINE AND CELLULAR LONGEVITY, 2022, 9682507. HTTPS://DOI.ORG/10.1155/2022/9682507. MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A MULTI-CENTER COHORT STUDY WAS DONE BETWEEN OCTOBER 2012 AND OCTOBER 2018 WITH FOLLOW-UP ENDING IN MARCH 2019. OF THE 258 REFERRED FOR TREATMENT, 69 PATIENTS WERE INCLUDED IN THE STUDY CRITERIA. 51 OF THE 69 PATIENTS INCLUDED IN THE STUDY UNDERWENT ENDOVASCULAR TREATMENT OF INTRACRANIAL VERTEBROBASILAR ARTERY LARGE TRUNK ANEURYSMS. ENDOVASCULAR TREATMENT WAS FURTHER DIVIDED INTO 3 SUBGROUPS: RECONSTRUCTIVE TECHNIQUE (WHICH INCLUDED COILING, STENT-ASSISTED COIL, AND FLOW DIVERSION (FD), DECONSTRUCTIVE TECHNIQUE (WHICH INCLUDED PARENT ARTERY SACRIFICE AND ANEURYSM EMBOLIZATION COMBINED WITH PARENT ARTERY SACRIFICE USING UNSPECIFIED COILS), AND RECONSTRUCTION AND DECONSTRUCTION COMBINED TECHNIQUE (IN WHICH RECONSTRUCTION THERAPY ENSURED THE UNOBSTRUCTED PARENT ARTERY, AND UNILATERAL VERTEBRAL ARTERY SACRIFICING REDUCED THE BLOOD FLOW TO THE ANEURYSM). IT WAS INDICATED THAT 2 PATIENTS HAD A SOLITAIRE STENT IMPLANTED AND 5 PATIENTS HAD PIPELINE STENTS IMPLANTED; 60 PATIENTS HAD NON-MEDTRONIC STENTS IMPLANTED. ADVERSE EVENTS REPORTED IN THE ARTICLE DID NOT SPECIFY WHICH DEVICES WERE USED IN THE PATIENTS WHO EXPERIENCED ADVERSE EVENTS. NO DEVICE MALFUNCTIONS OR INTRA-OPERATIVE ISSUES WERE REPORTED IN THE ARTICLE. ONE PATIENT DIED 30 OR MORE DAYS POST-OPERATIVE. THE CAUSE OF DEATH WAS NOT REPORTED IN THE ARTICLE. IT WAS NOT INDICATED WHETHER THE EVENT WAS RELATED TO THE PROCEDURE OR THE DEVICE(S) USED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT OF THE ADVERSE EVENTS THAT WERE MENTIONED WITHIN THE ARTICLE, NONE OF THEM WERE DIRECTLY RELATED TO MEDTRONIC DEVICES/PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896037 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Death