BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 20198426 · Received September 12, 2024

    Report

    Report Number
    9612164-2024-04164
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    April 16, 2024
    Report Date
    September 12, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿ EFFECTIVENESS AND SAFETY OF ENDOANCHORS IN ABDOMINAL AND THORACIC ENDOVASCULAR ANEURYSM REPAIR: A SYSTEMATIC REVIEW AND META-ANALYSIS¿.  TANG EWC, LAU ACK, CHENG JCH, WONG JC, CHAN YC. JOURNAL OF ENDOVASCULAR THERAPY 1¿17 HTTPS://DOI.ORG/10.1177/15266028241245911 A.2 <(>&<)> A.3 AVERAGE 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 ¿ EFFECTIVENESS AND SAFETY OF ENDOANCHORS IN ABDOMINAL AND THORACIC ENDOVASCULAR ANEURYSM REPAIR: A SYSTEMATIC REVIEW AND META-ANALYSIS¿.  A SYSTEMATIC REVIEW AND META-ANALYSIS ON THE EFFECTIVENESS AND SAFETY OF ENDOANCHORS IN ABDOMINAL AND THORACIC ENDOVASCULAR ANEURYSM REPAIR WAS PERFORMED. 16 EVAR AND 6 TEVAR STUDIES USING THE HELI-FX ENDOANCHOR SYSTEM WERE INCLUDED.  ENDURANT, TALENT, ANEURX, VALIANT, HELI FX AND NON MDT DEVICES WERE IMPLANTED IN PATIENTS ON UNKNOWN DATES. REGARDING THE ANATOMY OF THE AORTIC ANEURYSM, THE WEIGHTED MEAN OF AORTIC NECK LENGTH WAS 15.97 MM; NECK DIAMETER WAS 26.18 MM; NECK ANGULATION WAS 30.02 DEGREE; AND THE ANEURYSM SAC DIAMETER WAS 60.78 MM. THE MEAN FOLLOW-UP DURATION WAS 11.9 MONTHS.  THE FOLLOWING MALFUNCTIONS WERE REPORTED:  TYPE IA ENDOLEAK, MIGRATION THE FOLLOWING SERIOUS INJURIES WERE REPORTED;  RUPTURE , DISSECTION , MULTI-ORGAN FAILURE, EMBOLUS , INFECTION, RE-INTERVENTION PATIENT MORTALITY WAS REPORTED BUT THERE WAS NO CAUSAL LINK THAT A MDT DEVICE CAUSED OR CONTRIBUTED TO ANY DEATH.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505790 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown Required Intervention| O