BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA - FF

    MDR report key: 6756279 · Received August 1, 2017

    Report

    Report Number
    2953200-2017-01204
    Event Type
    Injury
    Date Received
    August 1, 2017
    Date of Event
    December 1, 2016
    Report Date
    July 12, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: VAMF3434C200TE LOT NUMBER UNKNOWN AND VAMF3434C100TE LOT NUMBER UNKNOWN. JOURNAL ARTICLE TITLE; TREATMENT INDICATIONS FOR AND OUTCOME OF ENDOVASCULAR REPAIR OF TYPE B INTRAMURAL AORTIC HEMATOMA MORITZ S. BISCHOFF, MD, KATRIN MEISENBACHER, MD, MICHAEL WEHRMEISTER, MD, DITTMAR BÖCKLER, MD, AND DROSOS KOTELIS, MD, HEIDELBERG, GERMANY; (J VASC SURG 2016;64:1569-79.) COPYRIGHT _ 2016 BY THE SOCIETY FOR VASCULAR SURGERY. PUBLISHED BY ELSEVIER INC. HTTP://DX.DOI.ORG/10.1016/J.JVS.2016.05.078 .

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEMS WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF TYPE B INTRAMURAL AORTIC HEMATOMA (EXACT DATE IS UNKNOWN). THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: OPEN CONVERSION, TYPE A DISSECTION. ABSTRACT OBJECTIVE: THE AIM OF THIS STUDY WAS TO ANALYZE THE OUTCOME OF THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) AND MEDICAL THERAPY IN PATIENTS WITH AORTIC INTRAMURAL HEMATOMA TYPE B (IMHB). METHODS: BETWEEN JANUARY 2004 AND JANUARY 2014, 41 IMHB PATIENTS WERE TREATED; 28 UNDERWENT TEVAR (16 MALE; MEDIAN AGE, 69 YEARS; GROUP I) PLUS BEST MEDICAL THERAPY (BMT), WHEREAS 13 HAD BMT ALONE (6 MALE; MEDIAN AGE, 69 YEARS; GROUP II). STUDY END POINTS WERE ASSESSMENT OF INDICATIONS FOR TEVAR AND BMT, CLINICAL OUTCOME, AND EVALUATION OF AORTIC MORPHOLOGY OVER TIME. MEDIAN FOLLOW-UP WAS 32 MONTHS FOR GROUP I AND 40 MONTHS FOR GROUP II. RESULTS: IN GROUP I, TEVAR WAS IMMEDIATELY PERFORMED IN 7 OF 28 CASES BECAUSE OF PAIN AND IMAGING RESULTS (PENETRATING AORTIC ULCERS, N = 4; INTRAMURAL BLOOD POOLS, N = 3). IN 21 OF 28 CASES, TEVAR WAS UNDERTAKEN BECAUSE OF CLINICAL OR RADIOLOGIC SIGNS OF PROGRESSION AT A MEDIAN OF 10 DAYS (RANGE, 2-223 DAYS). THE MEDIAN NUMBER OF STENT GRAFTS IMPLANTED WAS TWO (RANGE, 1-3). THE MEDIAN LENGTH OF COVERED AORTA WAS 15 CM (RANGE, 9.5-33.4 CM). TECHNICAL SUCCESS WAS ACHIEVED IN 25 OF 28. IN-HOSPITAL MORTALITY WAS 1 OF 28 IN GROUP I AND 0 OF 13 IN GROUP II. SURVIVAL IN GROUP I WAS 81.5%, 77.8%, AND 67% AT 1, 2, AND 4 YEARS. THERE WAS NO DEATH IN GROUP II DURING FOLLOW-UP. AORTIC REINTERVENTIONS WERE PERFORMED IN 6 OF 28 GROUP I CASES, INCLUDING 2 OPEN CONVERSIONS FOR RETROGRADE TYPE A DISSECTION. AORTIC DIAMETER DECREASED DURING FOLLOW-UP IN 10% IN GROUP I (VS 3% IN GROUP II; P = .039). IN GROUP I, COMPLETE REMODELING WAS SEEN IN 7 OF 27, REGRESSION IN THE REMAINING 20. IN GROUP II, COMPLETE REMODELING WAS SEEN IN 3 OF 12; REGRESSION WAS SEEN IN 9 OF 12. NO PATIENT IN GROUP II REQUIRED INVASIVE TREATMENT. CONCLUSIONS: BMT IS JUSTIFIED IN UNCOMPLICATED IMHB. HOWEVER, IMHB BECOMES COMPLICATED IN THE MAJORITY OF PATIENTS WITHIN 20 DAYS. TEVAR IN COMPLICATED IMHB IS FEASIBLE BUT ASSOCIATED WITH A SUBSTANTIAL AORTIC REINTERVENTION RATE, REFLECTING TECHNICAL CHALLENGES AND FRAGILE AORTIC WALL CONDITIONS. IT WAS REPORTED THAT THE PATIENT HAD A RETROGRADE TYPE A DISSECTION. THE PATIENT REQUIRED INTERVENTION AND A SUPRA-CORONARY ASCENDING AND HEMIARCH REPLACEMENT WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537578 VALIANT CAPTIVIA - FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VAMF3636C150TE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention