BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT NAVION

    MDR report key: 13415567 · Received February 1, 2022

    Report

    Report Number
    9612164-2022-00432
    Event Type
    Injury
    Date Received
    February 1, 2022
    Date of Event
    January 16, 2021
    Report Date
    February 1, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; A RARE CASE OF A BLUNT THORACIC AORTIC INJURY IN A PATIENT WITH ANABERRANT RIGHT SUBCLAVIAN ARTERY: A CASE REPORT AND LITERATURE REVIEW DIAZ B, MENESES E, KINSLOW K, MCKENNEY M, ELKBULI A, BONEVA D INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS 79 (2021) 172¿177 HTTPS://DOI.ORG/10.1016/J.IJSCR.2021.01.017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A PATIENT PRESENTED TO HOSPITAL WITH MULTIPLE INJURIES FOLLOWING A RTA . ONE OF THE INJURIES INCLUDED A GRADE 3 BLUNT THORACIC AORTIC INJURY DISTAL TO AN ABERRANT RIGHT SUBCLAVIAN ARTERY WHICH ORIGINATED FROM THE AORTIC ARCH. THE PATIENT UNDERWENT BILATERAL PERCUTANEOUS FEMORAL ARTERY ACCESS UNDER ULTRASOUND GUIDANCE, THORACIC ANGIOGRAM, THORACIC ENDOVASCULAR AORTIC REPAIR WITH A VALIANT NAVION STENT GRAFT AND A RIGHT COMMON CAROTID ARTERY TO RIGHT SUBCLAVIAN ARTERY BYPASS. ON POSTOPERATIVE DAY 1, A REPEAT CTA CHEST REVEALED A TYPE II ENDOLEAK THAT WAS MOST LIKELY DUE TO THE RIGHT CAROTID TO SUBCLAVIAN BYPASS RELATED TO RETROGRADE PERFUSION IN THE ABERRANT RIGHT SUBCLAVIAN ARTERY. DUE TO THE FINDING OF THE REPEAT CTA CHEST, THE PATIENT WAS TAKEN ON POSTOPERATIVE DAY 2 FOR A PLUG EMBOLIZATION OF THE ABERRANT RIGHT SUBCLAVIAN ARTERY THROUGH A RIGHT BRACHIAL ARTERY APPROACH. ON THE MORNING OF POST-OPERATIVE DAY 6, THE PATIENT WAS NOTED TO HAVE A CHANGE IN PULSE EXAM OF THE LEFT UPPER EXTREMITY. A CTA OF THE LEFT UPPER EXTREMITY DEMONSTRATED LEFT BRACHIAL ARTERY OCCLUSION WITH DISTAL RECONSTITUTION OF HER RADIAL AND ULNAR ARTERIES, THE PATIENT WAS TAKEN TO SURGERY FOR LEFT BRACHIAL ARTERY EXPLORATION, OPEN EMBOLECTOMY WITH BALLOON CATHETERS OF THE LEFT BRACHIAL, RADIAL, AND ULNAR ARTERIES, AND PRIMARY REPAIR OF THE LEFT BRACHIAL ARTERY. THE PATIENT UNDERWENT MULTIPLE OTHER INTERVENTIONS FOR THE OTHER INJURIES RECEIVED IN THE RTA. A FOLLOW-UP CT ANGIOGRAM WAS ALSO DONE. THIS SHOWED STABLE THORACIC AORTIC ARCH STENT AND A PATENT RIGHT COMMON CAROTID TO RIGHT AXILLARY BYPASS GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528280 VALIANT NAVION SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-NAV

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other| R