BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT BIFURCATED STENT GRAFT

    MDR report key: 5568353 · Received April 11, 2016

    Report

    Report Number
    2953200-2016-00748
    Event Type
    Injury
    Date Received
    April 11, 2016
    Date of Event
    February 21, 2015
    Report Date
    March 23, 2016
    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

    CORRECTED INFORMATION: SEX. 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; ENDOVASCULAR TREATMENT OPTIONS FOR COMPLEX ABDOMINAL AORTIC ANEURYSMS. SONIA RONCHEY,MD, EUGENIA SERRAO,MD, HOLTA KASEMI,MD, FELICE PECORARO,MD, STEFANO FAZZINI,MD, VITTORIO ALBERTI,MD, AND NICOLA MANGIALARDI,MD. J VASCINTERVRADIOL2015;26:842¿854. AN ENDURANT STENT GRAFT SYSTEMS WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF PARARENAL AORTIC ANEURYSM ALONG WITH CHIMNEY TECHNIQUE IN THE LEFT RENAL ARTERY. THE FOLLOWING INFORMATION IS REVIEWED IN THIS JOURNAL ARTICLE: SENSITIVE DEFICIT LEFT UPPER LIMB; ACUTE RENAL IN SUFFICIENCY. PURPOSE: TO REPORT SHORT-TERM AND MIDTERM OUTCOMES OF ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF COMPLEX ANEURYSMS REQUIRING REVASCULARIZATION OF VISCERAL ARTERIES. MATERIALS AND METHODS: PROSPECTIVE DATA WERE COLLECTED FROM PATIENTS DEEMED UNSUITABLE FOR CONVENTIONAL EVAR AND CONVENTIONAL SURGERY WHO WERE TREATED WITH DIFFERENT ENDOVASCULAR APPROACHES ACCORDING TO THE CLINICAL PRESENTATION OF THE ANEURYSM. CUSTOM-MADE FENESTRATED ENDOVASCULAR ANEURYSM REPAIR (CM F-EVAR) WAS USED IN THE ELECTIVE SETTING, HOMEMADE FENESTRATED ENDOVASCULAR ANEURYSM REPAIR (HM F-EVAR) OR HM F-EVAR COMBINED WITH CHIMNEY ENDOVASCULAR ANEURYSM REPAIR (CH-EVAR) WAS USED IN THE EMERGENT SETTING IN PATIENTS WITH HEMODYNAMIC STABILITY, AND CH-EVAR WAS USED IN UNSTABLE CASES. THE STUDY INCLUDED 34 CONSECUTIVE PATIENTS. PRIMARY OUTCOMES MEASURED WERE PERIOPERATIVE MORTALITY AND MORBIDITY, RENAL FUNCTION IMPAIRMENT (RFI), TARGET VESSEL PATENCY, AND SURVIVAL AT MEAN FOLLOW-UP. RESULTS: IN THE CM F-EVAR GROUP (7 OF 34 PATIENTS; 20.6%), AN INTRAOPERATIVE TYPE III ENDOLEAK (1 OF 7 PATIENTS; 14%) SEALED SPONTANEOUSLY. AT 8.9 MONTHS OF FOLLOW-UP, 1 (1 OF 7 PATIENTS; 14%) DEATH AND 1 (1 OF 7 PATIENTS; 14%) EPISODE OF TRANSIENT RFI WERE DOCUMENTED. VISCERAL VESSEL PATENCY RATE WAS 95.2%. IN THE HM F-EVAR GROUP (4 OF 34 PATIENTS; 11.7%) AND THE COMBINATION OF HM F-EVAR AND CH-EVAR GROUP (3 OF 34 PATIENTS; 8.8%), NO COMPLICATIONS WERE OBSERVED AT 17.3 MONTHS OF FOLLOW-UP. IN THE CH-EVAR GROUP (20 OF 34 PATIENTS; 58.8%), VISCERAL PATENCY WAS 95% AT 30.9 MONTHS OF FOLLOW-UP. TWO CASES OF TRANSIENT RFI AND 2 CASES OF PERMANENT RFI WERE REGISTERED (2 OF 20 PATIENTS; 10%). ONE ASYMPTOMATIC RENAL ARTERY BRANCH OCCLUSION WAS OBSERVED AT 11 MONTHS OF FOLLOW-UP. NO ENDOLEAKS WERE DOCUMENTED. CONCLUSIONS: ENDOVASCULAR ANEURYSM REPAIR TECHNIQUES INCLUDING CM F-EVAR, HM F-EVAR OR HM F-EVAR IN COMBINATION WITH CH-EVAR, AND CH-EVAR ARE VALID TOOLS TO MAINTAIN BLOOD FLOW IN VISCERAL ARTERIES DURING TREATMENT OF COMPLEX AORTIC ANEURYSMS. THE PROPOSED INTERVENTIONAL PROTOCOL BASED ON CLINICAL PRESENTATION WAS FEASIBLE IN ALL CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222544 ENDURANT BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ENBF2820C170EE

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR