BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 10715627 · Received October 21, 2020

    Report

    Report Number
    2247858-2020-00050
    Event Type
    Injury
    Date Received
    October 21, 2020
    Date of Event
    September 24, 2020
    Report Date
    December 30, 2020
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INVOLVED WITH THREE DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR 2247858-2020-00048. DEVICE 2 IS BEING REPORTED UNDER MDR 2247858-2020-00049. DEVICE 3 IS BEING REPORTED UNDER MDR 2247858-2020-00050.

    Description of Event or Problem · 0

    "ENDOVASCULAR ANEURYSM REPAIR OCCURRED ON (B)(6) 2020 AT PALO ALTO VA BY DR. (B)(6) . FINAL INTRAOPERATIVE ANGIO REVEALED A SLIGHT POTENTIAL TYPE 1A, BUT WAS INCONCLUSIVE. BALLOONING OF PLZ TOOK PLACE ALONG WITH THE AORTIC BIFURCATION AND THE ILIACS DOWN TO THE ILIAC BIFURCATIONS. A SECOND ANGIO WAS DONE INTRAOPERATIVELY AND INFLOW AND OUTFLOW WAS COMPLETE WITH NO DELAYS OR IMPINGEMENTS OF THE LIMBS. PATIENT CAME IN ON (B)(6) 2020 FOR A LEFT LIMB THROMBOSIS, WHICH WAS PRESENT FROM THE ENDOGRAFT FLOW DIVIDER DOWN THRU THE LEFT ILIAC. A REINTERVENTION WAS PERFORMED WITH KISSING BALLOONS AND KISSING STENTS IN THE LILAC." PATIENT OUTCOME: "NO KNOWN INJURIES CAUSED TO THE PATIENT."

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS INVOLVED WITH THREE DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR 2247858-2020-00048. DEVICE 2 IS BEING REPORTED UNDER MDR 2247858-2020-00049. DEVICE 3 IS BEING REPORTED UNDER MDR (B)(4).

    Description of Event or Problem · 1

    "ENDOVASCULAR ANEURYSM REPAIR OCCURRED ON (B)(6) 2020 AT (B)(6) BY DR. (B)(6). FINAL INTRAOPERATIVE ANGIO REVEALED A SLIGHT POTENTIAL TYPE 1A, BUT WAS INCONCLUSIVE. BALLOONING OF PLZ TOOK PLACE ALONG WITH THE AORTIC BIFURCATION AND THE ILIACS DOWN TO THE ILIAC BIFURCATIONS. A SECOND ANGIO WAS DONE INTRAOPERATIVELY AND INFLOW AND OUTFLOW WAS COMPLETE WITH NO DELAYS OR IMPINGEMENTS OF THE LIMBS. PATIENT CAME IN ON (B)(6) 2020 FOR A LEFT LIMB THROMBOSIS, WHICH WAS PRESENT FROM THE ENDOGRAFT FLOW DIVIDER DOWN THRU THE LEFT ILIAC. A REINTERVENTION WAS PERFORMED WITH KISSING BALLOONS AND KISSING STENTS IN THE LILAC." PATIENT OUTCOME: "NO KNOWN INJURIES CAUSED TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174460 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2006030103

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| R