BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FENESTRATED GRAFT

    MDR report key: 16417325 · Received February 22, 2023

    Report

    Report Number
    3005580113-2023-00029
    Event Type
    Injury
    Date Received
    February 22, 2023
    Report Date
    February 22, 2023
    Manufacturer
    WILLIAM A. COOK AUSTRALIA, PTY LTD
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE PROBLEM: A27 - APPROPRIATE TERM/CODE NOT AVAILABLE SELECTED FOR OCCLUSION.

    Description of Event or Problem · 0

    SABINA M. SORONDO 2022, "LARGE FENESTRATIONS VERSUS SCALLOPS FOR THE SUPERIOR MESENTERIC ARTERY DURING FENESTRATED ENDOVASCULAR ANEURYSM REPAIR: DOES IT MATTER?" THE STUDY SOUGHT TO COMPARE MIDTERM CLINICAL OUTCOMES AND SAC REGRESSION OF PATIENTS TREATED WITH THE COOK ZFEN, FROM SEPTEMBER 2021 TO JULY 2021, BETWEEN THE 2 DIFFERENT SMA CONFIGURATIONS: SMA SCALLOP OR LARGE FENESTRATION. 137 ZFEN PATIENTS HAD EITHER A SCALLOP OR A LARGE FENESTRATION FOR THE SMA AS THE PROXIMAL-MOST CONFIGURATION. OF THESE, 72 PATIENTS (52.6%) UNDERWENT REPAIR UTILIZING A SCALLOP CONFIGURATION, AND 65 PATIENTS (47.4%) UNDERWENT A LARGE FENESTRATION. THE PRIMARY OUTCOME OF INTEREST WAS SAC REGRESSION AT 1 YEAR. SECONDARY OUTCOMES INCLUDED PROXIMAL NECK REINTERVENTION RATES, 30-DAY MORTALITY, AND AN OVERALL 3-YEAR SURVIVAL. ALL FIRST POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SCANS (1-30 DAYS) WERE ANALYZED INDEPENDENTLY FOR PROXIMAL SEAL ZONE LENGTHS. PROXIMAL SEAL ZONE LENGTH WAS DEFINED AS THE DISTANCE FROM THE PROXIMAL GRAFT FABRIC TO THE START OF THE ANEURYSM IN LARGE FENESTRATIONS AND THE DISTANCE FROM THE BASE OF THE SCALLOP TO THE ANEURYSM FOR SCALLOP CONFIGURATIONS. ANEURYSM CHARACTERISTICS AND MORPHOLOGY RELATED TO THE NECK DIFFERED SIGNIFICANTLY BETWEEN THE 2 CONFIGURATIONS. WHILE MAXIMUM ANEURYSMSIZE DID NOT DIFFER SIGNIFICANTLY BETWEEN THE SCALLOP AND LARGE FENESTRATION GROUPS (61.6 ± 13.2 MM VS. 63.7 ± 13.4 MM, P = 0.33), THE SCALLOP GROUP HAD A SIGNIFICANTLY SMALLER INFRARENAL NECK DIAMETER (25.0 ± 5.32 VS. 26.9 ± 6.26, P = 0.044), LARGER SUPRARENAL NECK ANGULATION (24.3 ± 19.0 VS. 16.7 ± 11.1, P = 0.003), AND SMALLER DEVICE DIAMETER (29.5 ± 3.24 VS. 31.5 ± 3.23, P = 0.0002) AS COMPARED TO THE LARGE FENESTRATION GROUP. WITH REGARDS TO PERIOPERATIVE OUTCOMES, OPERATIVE METRICS WERE NOT STATISTICALLY DIFFERENT, OTHER THAN A HIGHER VOLUME OF CONTRAST USE IN THE LARGE FENESTRATION GROUP (99.8 ± 41.6 ML VS. 87.9 ± 32.3 ML, P = 0.0485). FLUOROSCOPY TIME, ESTIMATED BLOOD LOSS, AND EARLY REINTERVENTION RATES (<30 DAYS) WERE NOT STATISTICALLY DIFFERENT AMONG THE 2 GROUPS. REINTERVENTIONS WITHIN 30 DAYS WERE PRIMARILY SECONDARY TO RENAL ARTERY BRANCH OCCLUSIONS, WITH ONLY 1 PATIENT IN THIS COHORT REQUIRING REINTERVENTION FOR AN SMA BRANCH OCCLUSION IN THE SCALLOP GROUP. THE MEAN PROXIMAL SEAL ZONE LENGTH WAS SIGNIFICANTLY GREATER FOR LARGE FENESTRATION VERSUS SCALLOP CONFIGURATIONS (41.7 ± 14.4 MM VS. 19.5 ± 7.9 MM, P < 0.001). ADDITIONALLY, THERE WAS NO DIFFERENCE IN SAC REGRESSION BETWEEN SCALLOPS AND LARGE FENESTRATIONS AT 1 YEAR (10.1 ± 10.9 VS. 11.0 ± 12.1, P = 0.635). SIGNIFICANT SAC REGRESSION, DEFINED AS >5 MM DECREASE, WAS OBSERVED IN 51.4% OF SCALLOPS AND 54.5% OF LARGE FENESTRATIONS AT 1 YEAR (P = 0.126). IMPORTANTLY FOR MIDTERM TECHNICAL SUCCESS, IN THIS COHORT, THERE WERE NO PERSISTING TYPE 1A ENDOLEAKS REQUIRING PROXIMAL NECK REINTERVENTIONS IN EITHER GROUP. ON MULTIVARIATE LOGISTIC REGRESSION ANALYSIS, INCORPORATING CLINICAL, PROCEDURAL, AND ANATOMIC COVARIATES, USE OF A LARGE FENESTRATION FOR THE SMA WAS NOT INDEPENDENTLY ASSOCIATED WITH SAC REGRESSION (ODDS RATIO: 1.01, 95% CONFIDENCE INTERVAL: [0.22-4.73], P = 0.988). (B)(4): 3 PATIENTS EXPERIENCED RENAL ARTERY BRANCH OCCLUSIONS (2 IN THE SCALLOP GROUP AND 1 IN THE LARGE FENESTRATION GROUP), WHICH ONE COULD ARGUE IS PARTIALLY INFLUENCED BY THE SMA CONFIGURATION, DEPENDING ON THE INTRAOPERATIVE MANIPULATIONS TO ALIGN ALL THE SMA AND RENAL INTENDED BRANCH ORIGINS. ALL 3 PATIENTS SUFFERING RENAL ARTERY OCCLUSIONS WERE RE-STENTED WITH FULL RECOVERY OF RENAL FUNCTION AND NORMALIZATION OF CREATININE UPON SUBSEQUENT FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676011 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