BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FENESTRATED GRAFT

    MDR report key: 15894102 · Received December 1, 2022

    Report

    Report Number
    3005580113-2022-00123
    Event Type
    Injury
    Date Received
    December 1, 2022
    Report Date
    December 1, 2022
    Manufacturer
    WILLIAM A. COOK AUSTRALIA, PTY LTD
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM A JOURNAL ARTICLE COVERING RENAL STENT STENOSIS FOLLOWING ZFEN IMPLANT 12 PATIENTS: PATIENTS WERE DIVIDED INTO LARGE DIAMETER (LD) GROUP AND NORMAL DIAMETER (ND) GROUP. PATIENTS IN THE LARGE DIAMETER (LD) GROUP WERE TREATED WITH LARGER DIAMETER ZFEN DEVICES (EITHER 34 MM OR 36 MM). PATIENTS IN THE NORMAL DIAMETER (ND) GROUP WERE TREATED WITH LESS THAN/EQUAL TO 32 MM ZFEN DEVICES. PATIENTS WERE FOLLOWED POSTOPERATIVELY BY CTA [COMPUTER TOMOGRAPHY ANGIOGRAM] AND/OR DUPLEX ULTRASOUND. MEAN FOLLOW-UP TIME WAS 22 MONTHS. ONE HUNDRED (100) PATIENTS WERE TREATED FROM 2012-2017 WITH THE ZFEN DEVICE. IN ADDITION TO LARGER NECKS, PATIENTS IN THE LARGE DIAMETER (LD) GROUP HAD SHORTER, AND LESS ANGULATED INFRARENAL NECKS. PERCENT OVERSIZING WAS SIGNIFICANTLY LESS IN THE LARGE DIAMETER (LD) GROUP. LARGE DIAMETER (LD) GROUP 19.05% +/- 18.25%. NORMAL DIAMETER (ND) GROUP 24.27% +/- 12.01%. AAA DIAMETER FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 58.5 MM +/- 9.6 MM. AAA DIAMETER FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 61.0 MM +/- 17.4 MM. INFRARENAL NECK DIAMETER FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 23.4 MM +/- 3.2 MM. INFRARENAL NECK DIAMETER FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 30.1 MM +/- 5.3 MM. INFRARENAL NECK LENGTH FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 4.7 MM +/- 3.44 MM. INFRARENAL NECK LENGTH FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 2.6 MM +/- 2.9 MM. INFRARENAL ANGULATION FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 31.7 DEGREES +/- 19.4 DEGREES. INFRARENAL ANGULATION FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 21.5 DEGREES +/- 12.1 DEGREES. SUPRARENAL ANGULATION FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 24.8 DEGREES +/- 18.9 DEGREES. SUPRARENAL ANGULATION FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 16.5 DEGREES +/-15.8 DEGREES. RENAL OCCLUSIVE DISEASE FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 18. RENAL OCCLUSIVE DISEASE FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 8. 12 PATIENTS (5 ND GROUP, 7 LARGE DIAMETER (LD) GROUP) HAD RENAL STENT STENOSIS THAT REQUIRED REINTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2712371 ZENITH FENESTRATED GRAFT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM A. COOK AUSTRALIA, PTY LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention