BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX - UNK

    MDR report key: 21122954 · Received January 10, 2025

    Report

    Report Number
    9612164-2025-00198
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    July 26, 2024
    Report Date
    January 10, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿PREDICTORS FOR REINTERVENTION AND SURVIVAL DURING LONG-TERM FOLLOW-UP AFTER THORACIC ENDOVASCULAR AORTIC REPAIR FOR DESCENDING THORACIC AORTIC ANEURYSM¿ SALEM O, EL BEYROUTI H, MULORZ J, SCHELZIG H, IBRAHIM A, OBERHUBER A, DORWEILER B. JOURNAL OF VASCULAR SURGERY. 2024 NOV;80(5):1408-1417.E3. DOI: 10.1016/J.JVS.2024.07.087. 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 ¿PREDICTORS FOR REINTERVENTION AND SURVIVAL DURING LONG-TERM FOLLOW-UP AFTER THORACIC ENDOVASCULAR AORTIC REPAIR FOR DESCENDING THORACIC AORTIC ANEURYSM¿. THE TIME FRAME OF THIS STUDY WAS OVER A TWENTY-TWO YEAR PERIOD. MULTIPLE MANUFACTURES PRODUCTS WERE IMPLANTED. 305 PATIENTS WHO WERE TREATED WITH TEVAR FOR DEGENERATIVE DTAA WITH A MEAN AORTIC DIAMETER OF 64 MM WERE INCLUDED IN THE STUDY. VALIANT CAPTIVIA, ANEURX, TALENT AND NON-MDT STENT GRAFTS WERE IMPLANTED. AMONG THE PATIENT POPULATION THE FOLLOWING MALFUNCTIONS OCCURRED: IA ENDOLEAK, TYPE IB ENDOLEAK, TYPE III ENDOLEAK , MIGRATION THE FOLLOWING ADVERSE EVENTS OCCURRED: HEMORRHAGE, MULTIPLE ORGAN FAILURE, ISCHEMIA, STROKE, MYOCARDIAL INFRACTION, RENAL FAILURE, RESPIRATORY FAILURE, THROMBOSIS, DISSECTION, HEMATOMA, RUPTURE, INFECTION, FISTULA, INTERVENTION PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A MDT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATHS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367053 ANEURX - UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ANEURX

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown