BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT TAA STENT GRAFT

    MDR report key: 19134011 · Received April 18, 2024

    Report

    Report Number
    9612164-2024-01871
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    September 8, 2023
    Report Date
    April 18, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL  ARTICLE ENTITLED: COMPARISON OF CHIMNEY AND FENESTRATED TECHNIQUES FOR SUPRAAORTIC BRANCH REVASCULARIZATION DURING THORACIC ENDOVASCULAR AORTIC REPAIR: A SYSTEMATIC REVIEW AND META-ANALYSIS MINGYU LIU , XINYI WU ,  SONG WU,  XINYANG LI , SHIJIE XIN,  JIAN ZHANG CARDIOVASCULAR  INTERVENTIONAL  RADIOLOGY  (2023) 46:1315¿1328 HTTPS://DOI.ORG/10.1007/S00270-023-03537-4 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

    TALENT AND VALIANT STENT GRAFTS WERE IMPLANTED IN THORACIC ENDOVASCULAR AORTIC REPAIRS ON UNKNOWN DATES OVER A 22 YEAR PERIOD .  153 STUDIES WERE INCLUDED IN THIS SYSTEMATIC REVIEW.  THE PATIENTS IN THE STUDIES UNDERWENT EITHER FENESTRATED THORACIC ENDOVASCULAR AORTIC REPAIR (FTEVAR) OR CHIMNEY THORACIC ENDOVASCULAR AORTIC REPAIR ( CH-EVAR) OF AORTIC DISEASE. THE FOLLOWING MALFUNCTIONS WERE REPORTED:  TYPE IA ENDOLEAK, MIGRATION, DEFORMATION IN VIVO  THE FOLLOWING ADVERSE EVENTS WERE REPORTED;  STROKE, OCCLUSION  PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A MDT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2284601 TALENT TAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-TAL TAA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Unknown