BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER FX

    MDR report key: 16331864 · Received February 9, 2023

    Report

    Report Number
    2183870-2023-00050
    Event Type
    Injury
    Date Received
    February 9, 2023
    Date of Event
    May 16, 2022
    Report Date
    February 9, 2023
    Manufacturer
    COVIDIEN
    Product Code
    NTE
    PMA / PMN Number
    K063204
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    JOURNAL TITLE: SHORT-TERM OUTCOMES OF TRANSFEMORAL CAROTID ARTERY STENTING AND CAROTID ENDARTERECTOMY IN SYMPTOMATIC PATIENTS: DATA FROM A MULTICENTRIC PROSPECTIVE REGISTRY IN BRAZIL ANN VASC SURG 2022; 85: 41¿48 HTTPS://DOI.ORG/10.1016/J.AVSG.2022.04.053. 2022 ELSEVIER INC. ALL RIGHTS RESERVED. DATE OF EVENT: DATE OF PUBLICATION. PATIENT SEX:: MAJORITY GENDER, PATIENT AGE: AVERAGE AGE. 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

    MEDTRONIC RECEIVED AN ARTICLE TITLED 'SHORT-TERM OUTCOMES OF TRANSFEMORAL CAROTID ARTERY STENTING AND CAROTID ENDARTERECTOMY IN SYMPTOMATIC PATIENTS: DATA FROM A MULTICENTRIC PROSPECTIVE REGISTRY IN BRAZIL' THE PURPOSE OF THIS STUDY WAS TO DESCRIBE THE PRACTICE AND THE OUTCOMES OF CAROTID ARTERY STENTING (TF-CAS) AND CAROTID ENDARTERECTOMY (CEA) IN SYMPTOMATIC PATIENTS IN PUBLIC UNIVERSITY HOSPITALS IN BRAZIL, USING DATA FROM A PROSPECTIVE MULTICENTRIC REGISTRY. MEDTRONIC DEVICES USED IN THE PROCEDURES INCLUDED CRISTALLO IDEALE AND PROTÉGÉ RX STENTS AND SPIDER FX AND MOMA EMBOLIC PROTECTION DEVICES. OUTCOMES INCLUDED DEATH, STOKE, MI AND MAJOR CARDIOVASCULAR EVENT (MACE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461965 SPIDER FX TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE COVIDIEN UKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male