BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHENOM

    MDR report key: 16372563 · Received February 14, 2023

    Report

    Report Number
    2029214-2023-00273
    Event Type
    Death
    Date Received
    February 14, 2023
    Date of Event
    February 22, 2022
    Report Date
    February 14, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    PMA / PMN Number
    K151638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEPARATE REPORTS WILL BE SUBMITTED FOR SERIOUS PATIENT INJURIES WITHOUT MORTALITY. ASSOCIATED WITH MDR #: 2029214-2023-00272. REPORT PATIENT SEX (FEMALE) IS REPRESENTATIVE OF THE MAJORITY OF PATIENT INCLUDED IN THE STUDY. 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

    SWEID, A., SAJJA, K. C., MOUCHTOURIS, N., WEINBERG, J. H., SHIVASHANKAR, K., SAAD, H., ABBAS, R., EL NAAMANI, K., RAMESH, S., SCHAEFER, J., SAIEGH, F. A., JABBOUR, P., HERIAL, N. A., ZARZOUR, H., TJOUMAKARIS, S., ROMO, V., ROSENWASSER, R. H., <(>&<)> GOOCH, M. R. (2022). RESCUE STENTING FOR ACUTE ISCHEMIC STROKE WITH REFRACTORY EMERGENT LARGE VESSEL OCCLUSION IN THE MODERN THROMBECTOMY ERA. CLINICAL NEUROLOGY AND NEUROSURGERY, 215. HTTPS://DOI.ORG/10.1016/J.CLINEURO.2022.107183 MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A RETROSPECTIVE REVIEW OF PATIENT WHO UNDERWENT A MECHANICAL THROMBECTOMY PROCEDURE FOR LARGE VESSEL OCCLUSION BETWEEN JANUARY 2010 AND OCTOBER 2019. SUBJECTS WITH MTICI 0¿2 A AFTER AT LEAST THREE PASSES WERE DEFINED AS FAILED MT AND CONSTITUTED THE CONTROL GROUP (NSG-CONTROLS). PATIENTS THAT RECEIVED A RESCUE STENT (RSG) FORMED THE STUDY GROUP. IT WAS NOTED IN THE ARTICLE THAT MEDTRONIC MICROCATHETERS (MARKSMAN, PHENOM 27, AND PHENOM 21) WERE UTILIZED FOR DELIVERY OF THE NON-MEDTRONIC STENTS USED TO TREAT THE RSG PATIENTS BUT THE SPECIFIC CATHETER USED IN EACH CASE WAS NOT REPORTED. A TOTAL OF 34 PATIENTS WERE INCLUDED IN THE RSG. THERE WAS NO DEVICE MALFUNCTION REPORTED IN THE ARTICLE. 28 OR THE 34 RSG PATIENTS WERE NOTED TO HAVE A FAVORABLE OUTCOME AT THE END FOLLOW UP. MORTALITY RATE OF RSG PATIENTS WAS 15.2% (5 PATIENTS). THE SPECIFIC CAUSE OF DEATH AND RELATIONSHIP TO THE PROCEDURE, DEVICES USED, OR PATIENT INDEX OR UNDERLYING CONDITION WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673458 PHENOM CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-FG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death