BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 7078294 · Received December 4, 2017

    Report

    Report Number
    2953200-2017-01916
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    March 28, 2017
    Report Date
    December 4, 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; PERIOPERATIVE AND LATE OUTCOMES AFTER ENDOVASCULAR TREATMENT FOR ISOLATED ILIAC ARTERY ANEURYSMS. CLAUDIO BIANCHINI MASSONI, ANTONIO FREYRIE, MAURO GARGIULO, TIZIANO TECCHIO, CHIARA MASCOLI, ENRICO GALLITTO, GIANLUCA FAGGIOLI, RODOLFO PINI, MATTEO AZZARONE, PAOLO PERINI, AND ANDREA STELLA. ANN VASC SURG 2017; 44: 83¿93 HTTP://DX.DOI.ORG/10.1016/J.AVSG.2017.03.194 FDC24: UNSUITABLE PATIENT MORPHOLOGY. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT AND TALENT STENT GRAFT SYSTEMS WERE IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF ISOLATED ILIAC ARTERY ANEURYSMS. EVENTS REPORTED IN THE JOURNAL ARTICLE: STENOSIS, COMMON FEMORAL ARTERY INTIMAL FLAP, INGUINAL LYMPHORRHAGIA. OCCLUSION WITHIN THE DEVICE, INFOLDING. ABSTRACT: BACKGROUND: THE AIM OF THE STUDY IS TO REPORT EARLY AND FOLLOW-UP OUTCOMES OF THE ENDOVASCULAR TREATMENT WITH ILIAC ENDOGRAFTS FOR ISOLATED ILIAC ARTERY ANEURYSMS (IIAAS). METHODS: RECORDS OF PATIENTS WHO UNDERWENT ELECTIVE ENDOVASCULAR REPAIR FOR IIAA (BOTH PRIMARY AND PARA-ANASTOMOTIC) FROM 2005 TO 2015 IN 2 (B)(6) CENTERS WERE RETROSPECTIVELY EXAMINED. DEMOGRAPHIC DATA, PREOPERATIVE PATIENT COMORBIDITIES, ILIAC ANEURYSM CHARACTERISTICS, CONTRALATERAL ILIAC AXIS INVOLVEMENT, PATENCY OF HYPOGASTRIC ARTERIES AND INFERIOR MESENTERIC ARTERY (IMA), AND DATA OF ENDOVASCULAR TREATMENT WERE OBTAINED FOR ANALYSIS. EARLY END POINTS WERE TECHNICAL SUCCESS (TS), PERIOPERATIVE MORBIDITY, CLINICAL SUCCESS (CS), FREEDOM FROM RE-INTERVENTION (FFR) AND SURVIVAL. FOLLOW-UP END POINTS WERE CS, FFR, SURVIVAL, EVOLUTION OF THE ANEURYSMAL SAC, AND ENDOLEAK (EL). RESULTS: THIRTY-TWO IIAAS WERE TREATED THROUGH AN ENDOVASCULAR APPROACH IN 30 PATIENTS (MALE 96.7%; MEAN AGE 74.2 YEARS ± 7.6, RANGE 55E86). ANEURYSMS WERE PARA-ANASTOMOTIC IN 11 (34.4%) CASES. MEAN DIAMETER WAS 42.9 ± 15.6 MM (RANGE 30E100). TWENTY (62.5%) ANEURYSMS INVOLVED EXCLUSIVELY THE COMMON ILIAC ARTERY, 7 (21.9%) THE HYPOGASTRIC, AND 5 (15.6%) BOTH ARTERIES. IPSILATERAL HYPOGASTRIC ARTERY WAS STENOTIC OR OCCLUDED IN 4 (12.5%) AND 1 (3.1%) PATIENT, RESPECTIVELY. CONTRALATERAL HYPOGASTRIC ARTERY WAS OCCLUDED IN 2 (6.3%) CASES. IMA WAS PATENT IN 9 (30%) PATIENTS. THE OSTIUM OF THE HYPOGASTRIC ARTERY WAS PRESERVED IN 5 CASES (15.6%) AND VOLUNTARILY COVERED IN 27 (84.4%). ENDOVASCULAR EMBOLIZATION OF HYPOGASTRIC ARTERY WAS OBTAINED WITH A PLUG DEVICE IN 8 CASES (25%). HYPOGASTRIC SURGICAL REVASCULARIZATION WAS PERFORMED IN 2 CASES (6.3%). TS WAS 96.9%. THIRTY-DAY MORBIDITY WAS 6.3% (2/32). CS WAS 96.9% (1 ENDOGRAFT LIMB STENOSIS). THIRTY-DAY FFR WAS 90.6% (1 TRANSLUMINAL ANGIOPLASTY, 2 INGUINAL REVISIONS). THIRTY-DAY SURVIVAL WAS 100%. AT 1, 3, AND 6 YEARS, CS WAS 93.4%, 85.6%, AND 85.6%, RESPECTIVELY (1 ENDOGRAFT LIMB THROMBOSIS, 1 ENDOGRAFT LIMB STENOSIS, 1 HYPOGASTRIC TYPE II EL WITH SAC ENLARGEMENT). AT 1, 3, AND 6 YEARS, FFR WAS 87.5%, 76.8%, AND 76.8%, RESPECTIVELY (1 FIBRINOLYSIS THERAPY AND STENTING, 1 STENTING, 1 SURGICAL LIGATION OF HYPOGASTRIC ARTERY). AT 1, 3, AND 6 YEARS, SURVIVAL WAS 100%, 96.3%, AND 81.3%, RESPECTIVELY. NO AA RELATED DEATHS WERE REPORTED. DURING FOLLOW-UP, ANEURYSMAL DIAMETER WAS UNCHANGED IN 12 CASES (37.5%), DECREASED IN 19 (59.4%), AND INCREASED IN 1 (3.1%). TYPE II EL FROM HYPOGASTRIC ARTERY WAS DETECTED IN 3 CASES (9.4%) AND LED TO SAC ENLARGEMENT REQUIRING SURGICAL TREATMENT IN 1 CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857947 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention