BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 13252568 · Received January 13, 2022

    Report

    Report Number
    9612164-2022-00202
    Event Type
    Injury
    Date Received
    January 13, 2022
    Date of Event
    November 1, 2021
    Report Date
    January 14, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    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; SAFETY AND DURABILITY OF SINGLE-STAGE TYPE I HYBRID TOTAL AORTIC ARCH REPAIR FOR EXTENSIVE AORTIC ARCH DISEASE: EARLY- AND LONG-TERM CLINICAL OUTCOMES FROM A SINGLE CENTER AND OUR 10-YEAR OF EXPERIENCE ZHANG B, WEI Y, LIU Y, LIN H, LIANG S, DUN Y, YU C, QIAN X, GUO H, SUN X JOURNAL OF THORACIC DISEASE 2021;13(11):6230-6239 HTTP://DX.DOI.ORG/10.21037/JTD-20-3479. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    B5; CORRECTION TO ED THE FOLLOWING MALFUNCTIONS WERE REPORTED; TYPE IA ENDOLEAK THE FOLLOWING ADVERSE EVENTS WERE REPORTED ALSO; FALSE LUMEN ENLARGEMENT, PNEUMONIA. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    ENDURANT, VALIANT CAPTIVA STENT GRAFTS AND NON MDT STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF SINGLE-STAGE TYPE I HYBRID TOTAL AORTIC ARCH REPAIR. TYPE I HYBRID TOTAL AORTIC ARCH REPAIR WAS DEFINED AS SURGICAL TOTAL SUPRA-ARCH DEBRANCHING AND ZONE 0 STENT GRAFT DEPLOYMENT TO EXCLUDE THE ENTIRE DISEASED AORTIC ARCH. THE PATIENTS EXPERIENCED VARIOUS AORTIC PATHOLOGIES INCLUDING ANEURYSMS, DISSECTIONS AND AORTIC ULCERS. THE FOLLOWING ADVERSE EVENTS WERE REPORTED; STROKE, INFECTION, DISSECTION, RESPIRATORY FAILURE, RE-INTERVENTION, MULTI-ORGAN FAILURE , RENAL FAILURE PATIENT DEATHS WERE REPORTED BUT THERE IS NO CAUSAL LINK THAT A MDT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777937 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other| R