BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT NAVION

    MDR report key: 12605370 · Received October 11, 2021

    Report

    Report Number
    9612164-2021-03897
    Event Type
    Injury
    Date Received
    October 11, 2021
    Date of Event
    July 28, 2020
    Report Date
    October 11, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; SAFETY AND EFFICACY OF THE PERCUTANEOUS THORACIC ENDOVASCULAR REPAIR WITH REGIONAL ANESTHESIA DOMOTO S , AZUMA T , NAKAZAWA K2, YOKOI Y,HAYAKAWA M, YAMAGATA A, ISOMURA S, NOMURA M , NIINAMI H GENERAL THORACIC AND CARDIOVASCULAR SURGERY (2021) 69:267¿273 HTTPS://DOI.ORG/10.1007/S11748-020-01452-W. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT CAPTIVIA AND NON MDT STENT GRAFTS WERE IMPLANTED IN TEVAR PROCEDURES PERFORMED WITH GENERAL ANESTHESIA (GA) AND SURGICAL CUTDOWN (G-TEVAR). VALIANT NAVION AND A NON MDT STENT GRAFT WERE IMPLANTED AS PART OF A TEVAR PROCEDURE UTILIZING REGIONAL ANESTHESIA (RA) AND AN ARTERIOTOMY CLOSURE DEVICE (R-TEVAR). THE FOLLOWING ADVERSE EVENTS WERE REPORTED; SPINAL CORD ISCHEMIA (G- TEVAR GROUP). INADEQUATE HEMOSTASIS REQUIRING A SURGICAL CUTDOWN ( R- TEVAR GROUP) . THIS PATIENT REQUIRING THE CONVERSION HAD PREVIOUSLY UNDERGONE ENDOVASCULAR AORTIC REPAIR WITH SURGICAL FEMORAL CUTDOWN ON TWO OCCASIONS. ALTHOUGH THERE WAS LESSER CALCIFICATION AT THE PUNCTURE SITE AS OBSERVED BY COMPUTED TOMOGRAPHY, THE TISSUE AT THE PUNCTURE SITE WAS VERY HARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508631 VALIANT NAVION SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-NAV

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention