BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK-CV-SR

    MDR report key: 19298048 · Received May 13, 2024

    Report

    Report Number
    9612164-2024-02274
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    December 18, 2023
    Report Date
    May 13, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; OPEN VERSUS ZONE 0/1 ENDOVASCULAR AORTIC REPAIR FOR ARCH ANEURYSM: A PROPENSITY SCORE-MATCHED STUDY FROM THE NATIONAL CLINICAL DATABASE IN JAPAN YASUHISA OISHI, HIRAKU KUMAMARU, MASAAKI KATO, TAKAO OHKI, AKIRA SHIOSE, NOBORU MOTOMURA, HIDEYUKI SHIMIZU, ANNALS OF VASCULAR SURGERY, VOLUME 100, 2024, PAGES 128-137, HTTPS://DOI.ORG/10.1016/J.AVSG.2023.10.012 A.2, A3B 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

    MEDTRONIC STENT GRAFTS AND NON MDT STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENTS OF ZONE 0/1 ARCH ANEURYSMS ON UNKNOWN DATES OVER A THREE YEAR PERIOD . THE OUTCOMES OF THESE PATIENTS WERE COMPARED TO A SIMILAR GROUP OF PATIENTS WHO UNDERWENT OPEN SURGICAL REPAIR.  THE FOLLOWING MALFUNCTIONS WERE REPORTED;  TYPE I ENDOLEAK, TYPE III, TYPE IV ENDOLEAK  STROKE, PARAPLEGIA/PARAPARESIS, BLEEDING, PULMONARY DISTRESS, CARDIAC TAMPONADE, RENAL FAILURE, MYOCARDIAL INFRACTION, ATRIAL FIBRILLATION, MULTIPLE ORGAN FAILURE, INFECTION, DISSECTION, RE-INTERVENTION  PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A MEDTRONIC STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843215 UNK-CV-SR SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Unknown