BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR4

    MDR report key: 11929580 · Received June 3, 2021

    Report

    Report Number
    2029214-2021-00653
    Event Type
    Death
    Date Received
    June 3, 2021
    Date of Event
    April 27, 2021
    Report Date
    June 14, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    PMA / PMN Number
    K203358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.10.: REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. 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

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED THERE WAS NO DEVICE OR PROCEDURE ISSUES RELATED TO THE PATIENT'S DEATH. IT WAS DETERMINED THE CAUSE OF DEATH WAS MULTIPLE ORGAN FAILURE MESENTERIC THROMBOSIS THAT LEAD TO GASTRIC PNEUMATOSIS AND ISCHEMIC COLOPATHY WITH AN ONSET DATE OF (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REPORTING THAT A PATIENT UNDERWENT A MECHANICAL THROMBECTOMY PROCEDURE IN WHICH A SOLITAIRE X STENT RETRIEVER WAS USED. WITHIN 12-36 HOURS POST-PROCEDURE, THE PATIENT'S NEUROLOGICAL CONDITION DETERIORATED WITH NIHSS SCORE WORSENING 4 OR MORE POINTS FROM BASELINE AT 42. THE BASELINE NIHSS WAS NOT AVAILABLE. THE PATIENT DIED ON (B)(6) 2021. CAUSE OF DEATH WAS NOT REPORTED. THE PATIENT HAD A MEDICAL HISTORY OF: ATRIAL FIBRILLATION, HYPERLIPIDEMIA, HYPERTENSION, AND PERIPHERAL ARTERY DISEASE (PAD). THERE WAS NO REPORTED DEVICE MALFUNCTION OR INTRA-OPERATIVE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830606 SOLITAIRE FR4 CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR4-4-20-05 A971737

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death