BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 8606953 · Received May 14, 2019

    Report

    Report Number
    2953200-2019-00635
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    November 27, 2018
    Report Date
    May 14, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: "SINGLE-CENTER EXPERIENCE AND PRELIMINARY RESULTS OF INTRAVASCULAR ULTRASOUND IN ENDOVASCULAR ANEURYSM REPAIR." FELICE PECORARO, UMBERTO M. BRACALE, ARDUINO FARINA, GIOVANNI BADALAMENTI, FRANCESCA FERLITO, MARIO LACHAT, ETTORE DINOTO, VINCENZO ASTI, AND GUIDO BAJARDI. ANN VASC SURG 2019; 56: 209¿215, DOI: HTTPS://DOI.ORG/10.1016/J.AVSG.2018.09.016. ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED IN A PATIENT GROUP FOR ENDOVASCULAR AORTIC ANEURYSM REPAIR.   THE FOLLOWING ADVERSE EVENTS WERE OBSERVED IN THE PATIENT GROUP: LYMPHATIC FISTULA, ILIAC LIMB OCCLUSION. OUTCOMES TO ADVERSE EVENT: OUTCOME ATTRIBUTED TO ADVERSE EVENTS: OTHER - NONE REPORTED IN ARTICLE. ABSTRACT: BACKGROUND: INTRAVASCULAR ULTRASOUND (IVUS) HAS BEEN INTRODUCED AS DIAGNOSTIC ADJUNCT TO PROVIDE NEW INSIGHTS INTO THE DIAGNOSIS AND THERAPY OF VASCULAR DISEASE. HEREIN, WE COMPARED THE OUTCOMES OF CONVENTIONAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) AND EVAR WITH IVUS IN PATIENTS PRESENTING WITH INFRARENAL ABDOMINAL AORTIC ANEURYSM USING A PROPENSITY-MATCHED COHORT. METHODS: FROM MAY 2013 TO AUGUST 2017, 221 PATIENTS WERE RETROSPECTIVELY ANALYZED. OF THAT, 122 PATIENTS WERE ELIGIBLE FOR INCLUSION AND UNDERWENT PROPENSITY SCORE MATCHING. PERIOPERATIVE MORTALITY AND MORBIDITY, RENAL FUNCTION IMPAIRMENT, ENDOLEAK INCIDENCE, MEAN CONTRAST MEDIUM USAGE, OPERATIVE TIME, RADIATION EXPOSURE (INCLUDING FLUOROSCOPY TIME, DOSE-AREA PRODUCT [DAP], AND DIGITAL SUBTRACTION ANGIOGRAPHY [DSA] RUNS), SURVIVAL, AND FREEDOM FROM REINTERVENTION WERE THE OUTCOMES MEASURED. RESULTS: AFTER MATCHING, 52 PATIENTS WERE INCLUDED, 26 IN THE CONVENTIONAL EVAR GROUP AND 26 IN THE EVAR WITH IVUS GROUP. NO PERIOPERATIVE MORTALITY OR TYPE I/III ENDOLEAK WERE REGISTERED. ONE PERIOPERATIVE LYMPHATIC FISTULA AND ONE ILIAC LIMB OCCLUSION WERE OBSERVED. IN THE EVAR WITH IVUS GROUP, A SIGNIFICANT REDUCTION OF CONTRAST MEDIUM (92 [VS. 51 ± 17] VS. 51 [20E68] ML; P ¼ 0.003) AND RADIATION EXPOSURE INCLUDING FLUOROSCOPY TIME (12 [9E16] VS. 20 [12E25] MIN; P ¼ 0.001), DAP (15 [9E21] VS. 32 [16E44] G*CM2 ; P ¼ 0.002), AND DSA RUNS (2 [1E3] VS. 3 [2E4]; P ¼ 0.04) WAS REPORTED. NO DIFFERENCES WERE OBSERVED IN TERMS OF GLOMERULAR FILTRATION RATE (86 [45E121] VS. 90 [38E117] ML/MIN; P ¼ 0.14) AND OPERATION TIME (176 [124E210] VS. 179 [120E210]; P ¼ 0.48). SURVIVAL AT 36 MONTHS WAS 93% FOR STANDARD EVAR AND 92% FOR EVAR WITH IVUS (P ¼ 0.845). FREEDOM FROM REINTERVENTION AT 36 MONTHS WAS 85.5% IN BOTH THE GROUPS (P ¼ 0.834). CONCLUSIONS: IN THIS PRELIMINARY EXPERIENCE, THE USE OF IVUS DURING EVAR WAS FEASIBLE WITH NO REGISTERED POSTOPERATIVE COMPLICATIONS. A SIGNIFICANT REDUCTION OF CONTRAST MEDIUM USAGE AND RADIATION EXPOSURE WAS OBSERVED WITH THE USE OF IVUS. THE IVUS IS AN ADJUNCTIVE TOOL TO CONSIDER IN THE VASCULAR SURGEON ARMAMENTARIUM, ESPECIALLY IN CENTERS WHERE ADVANCED RADIOLOGICAL TOOLS OF IMAGING FUSION ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401804 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other