BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 7099292 · Received December 8, 2017

    Report

    Report Number
    2953200-2017-01937
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    May 6, 2017
    Report Date
    December 8, 2017
    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

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; PERIGRAFT SEROMA AFTER EXTRA-ANATOMIC BYPASS: CASE SERIES AND REVIEW OF THE LITERATURE DANIELE BISSACCO,1,2 MAURIZIO DOMANIN,1,2 SILVIA ROMAGNOLI,1 AND LIVIO GABRIELLI (ANN VASC SURG 2017; 44: 451¿458) HTTP://DX.DOI.ORG/10.1016/J.AVSG.2017.03.201. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR. THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR AN 8.25 CM AAA. A LEFT ENDURANT AUI STENT GRAFT TOGETHER WITH A LEFT TO RIGHT FF PTFE BYPASS GRAFT WERE PERFORMED. APPROXIMATELY 1 MONTH AFTER THE INDEX PROCEDURE, HE CAME BACK TO OUR DEPARTMENT BECAUSE OF A SMALL, PAINLESS MASS ALONG THE FEMORAL-FEMORAL BYPASS, PARTICULARLY CLOSE TO THE LEFT SECTION. AFTER 3 WEEKS PERCUTANEOUS ASPIRATION WAS PERFORMED AND THE PATIENT COMPLETELY RECOVERED. DOPPLER ULTRASOUND PERFORMED 6 MONTHS LATER REVEALED GRAFT PATENCY AND MILD ASYMPTOMATIC RECURRENCE. BACKGROUND: EXTRA-ANATOMIC BYPASS (EAB) REMAINS A VIABLE ALTERNATIVE FOR LOWER LIMB REVASCULARIZATION IF AORTO-BIFEMORAL BYPASS AND ENDOVASCULAR THERAPY ARE CONTRAINDICATED. AMONG EAB, PERIGRAFT SEROMA (PS) OCCURS IN ABOUT 4% OF CASES. DIAGNOSTIC AND THERAPEUTIC MANAGEMENT, AS WELL AS STANDARDIZED TREATMENT PARADIGM, ARE STILL NOT WELL DEFINED. THE AIM OF THIS STUDY IS TO REPORT 5 PS CASES IN EAB AND TO REVIEW THE LITERATURE ABOUT SIMILAR CASES. METHODS: WE RETROSPECTIVELY REVIEWED EAB PERFORMED DURING THE PERIOD 2002-2015. AMONG THESE, PS CASES WERE ANALYZED. A SIMILAR DESCRIPTION FOR ALL CASES FOUND IN THE LITERATURE THROUGH RESEARCH ON THE MAJOR INTERNATIONAL DATABASES (PUBMED, SCOPUS, EMBASE) WAS CONDUCTED. RESULTS: DURING THE STUDY PERIOD, 797 BYPASSES 528 (66.3%) ANATOMICAL AND 269 (33.7%) EXTRA-ANATOMICALDWERE PERFORMED. AMONG THE LATTER, 169 FEMORO-FEMORAL (FF), 20 AXILLOFEMORAL (AXF), 22 AXILLO-BIFEMORAL (AXBF), AND 58 AORTOUNI-ILIAC ENDOPROSTHESIS (AUI) + FF BYPASSES WERE PERFORMED. FIVE CASES (1.86%) OF PS IN EAB POPULATION WERE DETECTED: 3 AFTER AXBF AND 2 AFTER AUI + FF. ALTHOUGH WE INITIALLY PREFERRED PERCUTANEOUS DRAINAGE, A SURGICAL CHOICE WITH GRAFT EXPLANT AND REPLACEMENT WERE IMPOSED BY THE HIGH RECURRENCE RATE. LITERATURE ANALYSIS IDENTIFIED 20 ADDITIONAL CASES (11 AFTER AXBF, 7 AFTER AXF AND ONE AFTER AUI + FF). CONCLUSIONS: OUR CASE SERIES AND THE LITERATURE CONFIRM THAT THE MOST WIDELY USED THERAPY IS THE SURGICAL DRAINAGE WITH PRIMARY OR SECONDARY REPLACEMENT OF THE GRAFT OF A DIFFERENT MATERIAL. PERCUTANEOUS DRAINAGE HAS PROVED TO BE INEFFECTIVE BECAUSE NOT CONCLUSIVE AND POTENTIAL TO INCREASE RISK OF GRAFT INFECTION. CAREFUL FOLLOW-UP, EVEN YEARS AFTER SURGERY, REMAINS NECESSARY FOR PS DIAGNOSIS AND MANAGEMENT, TO PREVENT COMPLICATIONS AND POTENTIAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878833 ENDURANT II STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention