BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 7281615 · Received February 20, 2018

    Report

    Report Number
    2953200-2018-00248
    Event Type
    Death
    Date Received
    February 20, 2018
    Date of Event
    April 27, 2016
    Report Date
    February 20, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; ENDOVASCULAR REPAIR IN AORTIC AND ILIAC RUPTURE ANITA QUINTAS, HUGO VALENTIM, JOÃO ALBUQUERQUE E CASTRO, FREDERICO BASTOS GONC¸ALVES, RODOLFO ABREU, HUGO RODRIGUES, NELSON OLIVEIRA, GONC¸ALO RODRIGUES, RITA FERREIRA, NELSON CAMACHO, MARIA EMÍLIA FERREIRA E LUÍS MOTA CAPITÃO (HTTP://CREATIVECOMMONS.ORG/LICENSES /BY-NC-ND/4.0/). HTTP://DX.DOI.ORG/10.1016/J.ANCV.2016.04.006 1646706X/ © 2016 SOCIEDADE PORTUGUESA DE ANGIOLOGIA E CIRURGIA VASCULAR. PUBLICADO POR ELSEVIER ESPA¿NA, S.L.U. ESTE ´E UM ARTIGO OPEN ACCESS SOB UMA LICENC¸A CC BYNCND (HTTP://CREATIVECOMMONS.ORG/LICENSES/BYNCND/ 4.0/). EXACT DATE OF DEATH UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADVERSE EVENTS FOR ENDURANT AND TALENT; DEATH; 30 DAY MORTALITY, SERIOUS INJURY; LATE ANEURYSM RUPTURE FOLLOWING EVAR, ABDOMINAL COMPARTMENT SYNDROME, THROMBOSIS, WOUND REACTION, ILIAC DISSECTION, HAEMORRHAGE, RENAL INSUFFICIENCY, LIVER INSUFFICIENCY, PULMONARY ISSUES, MESENTERIC ISCHEMIA, CVA, MI, SEPSIS, CHOLECYSTITIS. MALFUNCTION; ENDOLEAK TYPE IB, ENDOLEAK TYPE II ABSTRACT INTRODUCTION: RUPTURE HAS A NEGATIVE IMPACT ON ABDOMINAL AORTIC OR ILIAC PATHOLOGY. ENDO-VASCULAR ANEURYSM REPAIR (EVAR) IS AN ESTABLISHED TREATMENT IN THE ELECTIVE SETTING WHICH HAS INCREASINGLY BEEN APPLIED IN URGENT PATIENTS AND MAY BE ASSOCIATED WITH A DECREASE IN PERIOPERATIVE MORTALITY. OBJECTIVES: OUR PRIMARY OUTCOME WAS PERIOPERATIVE/EARLY MORTALITY. SECONDARY OUTCOMES INCLUDE PERIOPERATIVE HEMODYNAMICS AND PROCEDURE-RELATED COMPLICATIONS. METHODS: A PROSPECTIVELY MAINTAINED SINGLE CENTER DATABASE WAS RETROSPECTIVELY ENQUIRED. PATIENTS WHO UNDERWENT REVAR BETWEEN (B)(6) 2008 AND (B)(6) 2014 WERE INCLUDED. RUPTURE WAS DEFINED AS THE PRESENCE OF A RETROPERITONEAL HEMATOMA OR EXTRAVERSION OF CONTRAST ON A CTA. ALTHOUGH THERE¿S NO INSTITUTIONAL CAPACITY TO OFFER EVAR TO ALL RUPTURED ANEURYSMS, IT IS GIVEN PREFERENCE TO ENDOVASCULAR REPAIR OVER OPEN SURGERY IN PATIENTS WITH SUITABLE AORTIC ANATOMY FOR EVAR. DEMOGRAPHIC, PERIOPERATIVE HEMODYNAMICS AND LABORATORIAL DATA WERE ASSESSED. PRIMARY OUT-COME WAS PERIOPERATIVE/EARLY MORTALITY. SECONDARY OUTCOMES INCLUDE PROCEDURE-RELATED ANDSYSTEMIC COMPLICATIONS. RESULTS: FORTY-NINE PATIENTS WERE INCLUDED, 43 OF WHOM (88%) WERE MALES AND MEAN AGE WAS 73.7 ± 10,61 YEARS (RANGE 47 TO 90). THIRTY-FIVE PATIENTS PRESENTED RAAA (72%) AND 9 RUPTURED ILIAC ANEURYSMS (18%). MEAN ANEURYSM DIAMETER WAS 7.6 ± 1.7 CM. OTHER INDICATIONS FOR REVAR WERE SPONTANEOUS/IATROGENICAORTIC RUPTURE (6%; N = 3), LATE ANEURYSM RUPTURE FOLLOWING EVAR (N = 1) AND A CASE OF AN ANASTO-MOTIC PSEUDOANEURYSM. DEPLOYED ENDOGRAFT CONFIGURATION WAS AORTIC BI-ILIAC IN 26 CASES (53%), AORTIC MONO-ILIAC IN 18 (37%) AND EMBOLIZATION AND ENDOVASCULAR EXCLUSION WITH ILIAC BRANCH (10%). DEPLOYED DEVICES WERE ENDURANT MEDTRONIC®IN 59%, EXCLUDER GORE®IN 12%, ZENITH COOK®IN 22%, EXCLUDER C3 GORE®IN 5%, E TALENT MEDTRONIC®IN 2%. 32% WERE TREATED UNDER LOCAL ANESTHESIA. THE 30 DIAS/INTRAHOSPITALAR MORTALITY RATE WAS 26.5%, WHICH PROGRESSIVELY DECREASED DURING THE STUDY PERIOD. THE 30-DAY COMPLICATION RATE WAS LOCAL IN 20.4%, SYSTEMICIN 53%. ABDOMINAL COMPARTMENT SYNDROME OCCURRED IN 10 CASES (20.4%), AND WAS FOUND TO BE A NEGATIVE PROGNOSTIC FACTOR. MEDIAN HOSPITALIZATION DURATION WAS 7 DAYS (0-92) AND MEDIAN STAY IN THE INTENSIVE CARE UNIT WAS 2 DAYS (0-65). CONCLUSION: EVAR IS A VALID TREATMENT IN THE URGENT SETTING FOR PATIENTS WITH ABDOMINAL AORTICOR ILIAC RUPTURE. OUR RESULTS ARE COMPARABLE TO THE RANDOMIZED CONTROLLED STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125286 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death