BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO ANCHOR SYSTEM - HELI-FX AAA

    MDR report key: 20083865 · Received August 28, 2024

    Report

    Report Number
    9612164-2024-03894
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    March 23, 2024
    Report Date
    September 3, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    OTD
    PMA / PMN Number
    K140036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ROBOTIC ASSISTED AORTIC BANDING FOR TYPE IA ENDOLEAK IBORRA E, HERRANZ-PINILLA C, LÓPEZ-COSTEA M EUR J VASC ENDOVASC SURG (2024) 67, 1032 HTTPS://DOI.ORG/10.1016/J.EJVS.2024.03.033 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING ¿ ROBOTIC ASSISTED AORTIC BANDING FOR TYPE IA ENDOLEAK¿ AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 70MM INFLAMMATORY ABDOMINAL AORTIC ANEURYSM WITH A SHORT CONICAL NECK ON AN UNKNOWN DATE. DESPITE THE USE OF BALLOONING AND THE IMPLANT OF ENDOANCHORS, A TYPE IA ENDOLEAK PERSISTED ON COMPLETION ANGIOGRAM AND POST-OPERATIVE CTA. AFTER DISCUSSION WITH THE MULTI-DISCIPLINARY TEAM, IT WAS DECIDED TO PERFORM AORTIC BANDING USING A ROBOTIC APPROACH. THIS WAS PERFORMED SUCCESSFULLY AND THE INTERVENTION PROCEDURE LASTED 100 MINUTES. THE PATIENT HAD AN UNEVENTFUL POST-OPERATIVE COURSE AND WAS DISCHARGED AFTER TWO DAYS. A POST-OPERATIVE CTA DID NOT NOTE A TYPE IA ENDOLEAK. AT SIX MONTHS, THE DUPLEX SCAN SHOWED NO ENDOLEAK. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464774 ENDO ANCHOR SYSTEM - HELI-FX AAA ENDOVASCULAR SUTURING SYSTEM OTD MEDTRONIC IRELAND SA-85 0011508579

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown Required Intervention