BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER FX

    MDR report key: 16625959 · Received March 28, 2023

    Report

    Report Number
    2183870-2023-00089
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    April 12, 2021
    Report Date
    March 28, 2023
    Manufacturer
    COVIDIEN
    Product Code
    NTE
    PMA / PMN Number
    K111010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: COMPLICATIONS AND FAILURE MODES OF CORONARY EMBOLIC PROTECTION DEVICES: INSIGHTS FROM THE MAUDE DATABASE AUTHORS: MICHAEL MEGALY, RAMEZ MORCOS , CHARL KHALIL , SANTIAGO GARCIA, MIR BASIR, BRIJESHWAR MAINI, HOUMAN KHALILI, NICHOLAS BURKE, KHALDOON ALASWAD, EMMANOUIL S. BRILAKIS, REFERENCE: DOI: 10.1002/CCD.29717 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 A JOURNAL ARTICLE TITLED 'COMPLICATIONS AND FAILURE MODES OF CORONARY EMBOLIC PROTECTION DEVICES: INSIGHTS FROM THE MAUDE DATABASE'. THE STUDY EXAMINED REPORTS OF CORONARY EPDS FAILURE REPORTED TO THE FOOD AND DRUG ADMINISTRATION (FDA) MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) REGISTRY. 119 REPORTS ON CORONARY EPD FAILURE (SPIDER FX N = 33 AND NON-MEDTRONIC N = 86) WERE RETRIEVED, MOST OF WHICH (78.2%) OCCURRED DURING SAPHENOUS VEIN GRAFT INTERVENTIONS. MODES OF FAILURE REPORTED FOR THE SPIDER FX DEVICE WERE FAILURE OF RETRIEVAL, 19 (57.6%) TRAPPED AGAINST STENT STRUTS 8 (42.1%) FILTER FRACTURE, 18 (54.5%) FAILURE OF CROSSING 2 (6.1%) AND FAILURE OF RECAPTURING, 3 (9.1%). THESE DEVICE FAILURES WERE MANAGED BY SUCCESSFUL CATHETER-BASED RETRIEVAL, SNARE, LEFT IN PATIENT, JAILED WITH A STENT OR SURGICAL RETRIEVAL. PATIENT COMPLICATIONS REPORTED INCLUDED STENT DEFORMATION DURING RETRIEVAL, NO REFLOW, SLOW FLOW, ACUTE STENT THROMBOSIS, CORONARY ARTERY DISSECTION, HEMODYNAMIC COLLAPSE, RESPIRATORY ARREST, EMBOLIZATION , AND PERIPROCEDURAL MI. NO STROKE OR DEATHS REPORTED IN THE SPIDER FX GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13745 SPIDER FX TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention