BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA STENT GRAFT

    MDR report key: 5628831 · Received May 3, 2016

    Report

    Report Number
    2953200-2016-00901
    Event Type
    Injury
    Date Received
    May 3, 2016
    Date of Event
    January 6, 2015
    Report Date
    April 11, 2016
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CONCLUSIONS: OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE (OUTSIDE OF INDICATION).

    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 (B)(6) 2002 TO (B)(6) 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 MORTALITY WAS 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¿0.97)]. 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
    281312 TALENT TAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention