BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO ANCHOR SYSTEM - HELI-FX AAA

    MDR report key: 20234891 · Received September 17, 2024

    Report

    Report Number
    9612164-2024-04238
    Event Type
    Injury
    Date Received
    September 17, 2024
    Date of Event
    April 4, 2024
    Report Date
    September 17, 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

    CITATION: AUTHORS: ANDRES REYES VALDIVIA, KYRIAKOS OIKONOMOU, ROSS MILNER, APOSTOLOS PITOULIAS, MICHEL M.P.J. REIJNEN, KARIN PFISTER, GIOVANNI TINELLI, CSABA CSOBAY-NOVAK, GIOVANNI PRATESI, LUIS MARIANO FERREIRA, JEAN-PAUL P.M. DE VRIES, AND ARINDAM CHAUDHURI ENDOSUTURED ANEURYSM REPAIR OF ABDOMINAL AORTIC ANEURYSMS WITH SHORT NECKS ACHIEVES ACCEPTABLE MIDTERM OUTCOMES - RESULTS FROM THE PERU REGISTRY; ANN VASC SURG 2024; 106: 80¿89 HTTPS://DOI.ORG/10.1016/J.AVSG.2024.01.002 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. 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 'ENDOSUTURED ANEURYSM REPAIR OF ABDOMINAL AORTIC ANEURYSMS WITH SHORT NECKS ACHIEVES ACCEPTABLE MIDTERM OUTCOMES¿RESULTS FROM THE PERU REGISTRY'. THE TIME FRAME OF THIS STUDY WAS OVER 9 YEARS. THE FOLLOWING MEDTRONIC DEVICES WERE USED: 'HELI-FX ENDOANCHOR SYSTEM. AMONG PATIENT ADVERSE EVENTS INCLUDED: TECHNICAL FAILURE, TYPE IA ENDOLEAKS AND REINTERVENTION. THE CAUSE OF THE ENDOLEAKS WERE UNDETERMINED. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808322 ENDO ANCHOR SYSTEM - HELI-FX AAA ENDOVASCULAR SUTURING SYSTEM OTD MEDTRONIC IRELAND SA-85

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention