BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 5628851 · Received May 3, 2016

    Report

    Report Number
    2953200-2016-00902
    Event Type
    Injury
    Date Received
    May 3, 2016
    Date of Event
    January 6, 2015
    Report Date
    April 11, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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; AORTIC ARCH ANEURYSM: SHORT- AND MID-TERM RESULTS COMPARING OPEN ARCH SURGERY AND THE HYBRID PROCEDURE ALEXANDRE CAZAVETA, XAVIER ALACOQUEB, BERTRAND MARCHEIXA, XAVIER CHAUFOURC, HERVE ROUSSEAUD, YVES GLOCKA AND BERTRAND LEOBONA (EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 49 (2016) 134-140) VALIANT, TALENT, AND VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AORTIC ARCH ANEURYSM. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: RESPIRATORY FAILURE, FISTULA, PNEUMONIA, STROKE, RENAL FAILURE, BLOOD LOSS, HEART FAILURE, HEMORRHAGIC SHOCK, NERVE INJURY, DISSECTION, RUPTURED ANEURYSM, TYPE I ENDOLEAK, TYPE II ENDOLEAK, TYPE A DISSECTION, VASCULAR ACCESS PROBLEM, INTERFEMORAL BYPASS AND ILIOFEMORAL BYPASS. ABSTRACT OBJECTIVES: OPEN ARCH SURGERY FOR AORTIC ARCH ANEURYSM WAS HISTORICALLY ASSOCIATED WITH A HIGH RISK OF POSTOPERATIVE MORBI-MORTALITY. IMPROVED OPERATIVE TECHNIQUES HAVE NOW LOWERED THE INCIDENCE OF THESE COMPLICATIONS BUT IN PARALLEL, HYBRID ARCH PROCEDURES HAVE EMERGED. NOWADAYS, VERY LITTLE DATA ARE AVAILABLE ABOUT THEIR MID-TERM RESULTS COMPARED WITH OPEN SURGERY. METHODS: FROM JANUARY 2002 TO JANUARY 2014, 46 PATIENTS HAD TREATMENT FOR AN EXCLUSIVE AORTIC ARCH ANEURYSM INCLUDING 25 OPEN ARCH SURGERIES AND 21 TYPE I HYBRID ARCH PROCEDURES IN OUR INSTITUTION. ALL CASES INVOLVED ARCH ANEURYSMS INVOLVING AT LEAST ONE CAROTID ARTERY (ZONE 0 AND ZONE 1). ANEURYSMS OF THE DISTAL ARCH AND DESCENDING AORTA WERE EXCLUDED (ZONE 2 AND BEYOND). RESULTS FROM A RETROSPECTIVE DATABASE ARE REPORTED. THERE WERE NO PATIENTS LOST TO THE FOLLOW-UP. RESULTS: THERE WAS NO SIGNIFICANT DIFFERENCE IN PREOPERATIVE COMORBIDITIES BETWEEN THE TWO GROUPS. THE INCIDENCE OF IN-HOSPITAL MORTALITYWAS SIMILAR AT 20% (5/25) FOR OPEN SURGERY AND 19% (4/21) FOR HYBRID PROCEDURE (P = 0.830). THE INCIDENCE OF PERMANENT CEREBRAL NEUROLOGICAL DEFICIT WAS COMPARABLE AT 17.4% (4/23) FOR OPEN SURGERY AND 21.1% (4/19) FOR HYBRID PROCEDURE (P = 1). MEDIAN SURVIVAL WAS 109.5 MONTHS FOR OPEN SURGERY AND 56.3 MONTHS FOR HYBRID PROCEDURE. FREEDOM FROM ALL-CAUSE MORTALITY WAS 78, 63, 63 AND 57% AT 1, 3, 5 AND 7 YEARS, RESPECTIVELY IN THE OPEN SURGICAL GROUP. FREEDOM FROM ALL-CAUSE MORTALITY WAS 74, 55, 46 AND 28% AT 1, 3, 5 AND 7 YEARS, RESPECTIVELY IN THE HYBRID GROUP. SURVIVAL RATES AND INCIDENCE OF MAJOR ADVERSE CARDIAC AND CEREBRO-VASCULAR EVENT BETWEEN OPEN SURGERY AND HYBRID PROCEDURE WERE NOT STATISTICALLY DIFFERENT (P = 0.530 AND P = 0.325, RESPECTIVELY). HOWEVER, INCIDENCE OF REINTERVENTION WAS IN FAVOUR OF OPEN SURGERY [14.5 VS 44.8% AT 7 YEARS, P = 0.045; 95% CONFIDENCE INTERVAL: (0.06㰮97)]. CONCLUSIONS: THE TYPE I HYBRID ARCH PROCEDURE FAILS TO DEMONSTRATE BETTER RESULTS COMPARED WITH OPEN SURGERY, REGARDING MORBI-MORTALITY AT THE SHORT- AND MID-TERM FOLLOW-UP. MOREOVER, IT INCREASES THE RISK OF REINTERVENTION. PATIENTS TREATED BY THIS TECHNIQUE MUST UNDERGO A CLOSER FOLLOW-UP BECAUSE OF THIS RISK. LARGER RANDOMIZED STUDIES ARE NEEDED TO BETTER DEFINE THE EXACT INDICATIONS OF THIS THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281942 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention