BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 6759447 · Received August 2, 2017

    Report

    Report Number
    2953200-2017-01215
    Event Type
    Death
    Date Received
    August 2, 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

    JOURNAL ARTICLE TITLED: 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 1569. 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

    THE PATIENT WAS ORIGINALLY TREATED WITH ANOTHER MANUFACTURER¿S TYPE B INTRAMURAL AORTIC HEMATOMA (EXACT DATE IS UNKNOWN). A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN EVENT THAT OCCURRED AFTER THE OTHER MANUFACTURER¿S DEVICE WAS IMPLANTED. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH. 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 ¼ .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 WAS ORIGINALLY TREATED WITH ANOTHER MANUFACTURER¿S STENT GRAFT SYSTEM AND HAD RECURRENT PAIN AND NEW BLOOD POOLING. THE PATIENT REQUIRED INTERVENTION AND ANOTHER MANUFACTURER¿S AS WELL AS A VALIANT DEVICE WAS IMPLANTED; HOWEVER, THE PATIENT EXPIRED 3 DAYS AFTER THIS INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540584 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death