BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 13585119 · Received February 23, 2022

    Report

    Report Number
    9612164-2022-00754
    Event Type
    Injury
    Date Received
    February 23, 2022
    Date of Event
    August 18, 2021
    Report Date
    February 23, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; BLUNT MESENTERIC VASCULAR INJURIES: ENDOVASCULAR MANAGEMENT AND MIDTERM OUTCOMES SAFAYA A, CARROLL F, LASKOWSKI I EJVES VASCULAR FORUM (2021) 53, 9E13 HTTPS://DOI.ORG/10.1016/J.EJVSVF.2021.08.001. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A PATIENT PRESENTED FOLLOWING A HIGH SPEED RTA. A CTA OF THE CHEST, ABDOMEN, AND PELVIS REVEALED AN INFRARENAL ABDOMINAL AORTIC DISSECTION, A PERI-AORTIC RETROPERITONEAL HAEMATOMA, AND FREE FLUID IN THE ABDOMEN. OTHER NON AORTIC RELATED INJURIES WERE ALSO DIAGNOSED. THE PATIENT WAS BROUGHT TO THEATRE, AN EMERGENCY AORTOGRAM IN THE OPERATING ROOM CONFIRMED AN INFRARENAL AORTIC INJURY WITH ACTIVE EXTRAVASATION. AN ENDURANT AORTIC CUFF WAS THEN PLACED WITH RESOLUTION OF THE EXTRAVERSION. HOWEVER, THE PATIENT CONTINUED TO BE HYPOTENSIVE WITH NO OTHER OBVIOUS SOURCE OF BLEEDING, WHICH PROMPTED AN EXPLORATORY LAPAROTOMY. THIS REVEALED MULTIPLE SMALL INTESTINAL MESENTERIC TEARS AND A 20 CM LENGTH OF DEVASCULARISED JEJUNUM THAT WAS RESECTED. BY POST-OPERATIVE DAY 6. THE PATIENTS LAB VALUES SHOWED SOME ABNORMALITIES. A CT ANGIOGRAM (CTA) OF THE ABDOMEN AND PELVIS SHOWED SEVERE FOCAL STENOSIS OF THE PROXIMAL CELIAC ARTERY (CA)AND SUPERIOR MESENTERIC ARTERY (SMA) WITH SMALL BOWEL DILATION, INFLAMMATION, AND EVIDENCE OF LIVER HYPOPERFUSION. WITH A DIAGNOSIS OF POST-TRAUMATIC DISSECTION OF VISCERAL ARTERIES THE PATIENT WAS BROUGHT TO THE HYBRID OPERATING ROOM FOR EMERGENCY REVASCULARISATION. A MESENTERIC ANGIOGRAM VIA LEFT BRACHIAL ARTERY ACCESS CONFIRMED SEVERE STENOSIS IN THE PROXIMAL SMA. A NON MDT BALLOON EXPANDABLE STENT WAS PLACED IN THE SMA AND THE CA STENOSIS WAS TREATED WITH 2 SELF EXPANDING NITINOL STENTS. COMPLETION ANGIOGRAPHY SHOWED AN EXCELLENT RADIOGRAPHIC RESULT WITH BRISK FLOW IN THE SMA AND CA. 69 DAYS AFTER THE INITIAL PRESENTATION, THE PATIENT WAS DISCHARGED TO A REHABILITATION UNIT. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686453 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Required Intervention