BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO ANCHOR SYSTEM - HELI-FX AAA

    MDR report key: 17681128 · Received September 5, 2023

    Report

    Report Number
    9612164-2023-03997
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    March 21, 2022
    Report Date
    September 5, 2023
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    OTD
    PMA / PMN Number
    K140036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; OFF-LABEL USE OF A CAROTID FILTER TO SOLVE AN UNEXPECTED COMPLICATION AT THE ACTIVE FIXATION OF ENDOANCHORS DURING EVAR ROSSELLA DI DOMENICO, AARON THOMAS FARGION, SARA SPEZIALI, ALBERTO MELANI, DAVIDE ESPOSITO, WALTER DORIGO, CARLO PRATESI, ANNALS OF VASCULAR SURGERY - BRIEF REPORTS AND INNOVATIONS, VOLUME 2, ISSUE 1, 2022, 100059 HTTPS://DOI.ORG/10.1016/J.AVSURG.2022.100059. 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

    AN ENDURANT II BIFURCATE STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 55MM AAA ON AN UNKNOWN DATE. THE AORTIC NECK WAS SHORT (9 MM LENGTH), ANGULATED (50°), WITH A MURAL THROMBUS <(><<)>2 MM THICK, INVOLVING LESS THAN 90° OF CIRCUMFERENCE, THEREFORE IT WAS PLANNED TO IMPLANT ENDOANCHORS PROPHYLACTICALLY TO PREVENT A TYPE IA ENDOLEAK. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE ENDURANT II STENT GRAFT WAS INSERTED AND DEPLOYED. SEVEN ENDOANCHORS WERE THEN IMPLANTED TO IMPROVE SEALING AND FIXATION. DURING DEPLOYMENT OF THE SECOND ENDOANCHOR, A STRUCTURAL FRACTURE OF ITS DISTAL PORTION CAUSED ITS ACCIDENTAL RELEASE IN THE AORTIC LUMEN AND THE FRAGMENT MOVED UPSIDE IN THE SUPRARENAL AORTA, CARRIED BY THE NONLAMINAR PERIPHERAL FLOW. SEVERAL ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE FRACTURED ENDOANCHOR INCLUDING USING THE HELI-FX GUIDE AND WITH A SNARING KIT. IT WAS THEN DECIDED TO USE A CAROTID FILTER, WHICH WAS SUCCESSFUL AND ADVANCED THE METAL FRAGMENT INSIDE THE GUIDING CATHETER. THE FINAL ANGIOGRAPHIC CONTROL SHOWED COMPLETE EXCLUSION OF THE ANEURYSMAL SAC WITH OPTIMAL PROXIMAL GRAFT APPOSITION IN ABSENCE OF ANY SIGN OF ENDOLEAK AND PATENCY OF BOTH RENAL ARTERIES. THE HOSPITAL STAY WAS UNEVENTFUL AND THE PATIENT WAS DISCHARGED IN THE SECOND POSTOPERATIVE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166178 ENDO ANCHOR SYSTEM - HELI-FX AAA ENDOVASCULAR SUTURING SYSTEM OTD MEDTRONIC IRELAND SA-85

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention