BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 3648448 · Received February 26, 2014

    Report

    Report Number
    2953200-2014-00346
    Event Type
    Death
    Date Received
    February 26, 2014
    Date of Event
    May 14, 2013
    Report Date
    February 3, 2014
    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

    EXACT DATE OF DEATH IS UNKNOWN. (B)(4). EVALUATION, RESULTS, CONCLUSION: KNOWN INHERENT RISK OF A PROCEDURE (ENDOLEAK, MIGRATION, CVA, DEATH, ISCHEMIA, MI, PARALYSIS, RENAL FAILURE, RUPTURE, OCCLUSION);(CAUSE IS UNKNOWN). (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. HYBRID AORTIC ARCH REPAIR FOR COMPLICATED TYPE B AORTIC DISSECTION CARSTEN M. BÜNGER, MD, PHD, STEPHAN KISCHE, MD, ANDREAS LIEBOLD, MD, PHD, MAXIMILIAN LEISSNER, AENNE GLASS, WOLFGANG SCHARECK, MD, PHD, HÜSEYIN INCE, MD, PHD, AND CHRISTOPH A. NIENABER, MD, PHD, HTTP:// DX. DOI. ORG/ 10.1016/ J.JVS.2013.05.091 THE FOLLOWING EVENTS WERE REPORTED: INTENTIONAL VESSEL COVERAGE, MIGRATION, UNINTENDED OCCLUSION, SNORKEL VASCULAR BYPASS, TYPE IA E NDOLEAK, TYPE I B ENDOLEAK, TYPE II ENDOLEAK, PNEUMONIA, STROKE, M.I., PERI-PROCEDURAL/POST-PROCEDURAL ASSOCIATED TYPE A DISSECTION, DEATH, MULTI-ORGAN FAILURE, ISCHEMIC COLITIS, RUPTURE. PARALYSIS, RENAL FAILURE. OBJECTIVE: THIS STUDY ANALYZED THE OUTCOME OF A COMBINED ENDOVASCULAR AND DEBRANCHING PROCEDURE FOR HYBRID AORTIC ARCH REPAIR (HAR) IN PATIENTS WITH COMPLICATED TYPE B AORTIC DISSECTION. METHODS: BETWEEN FEBRUARY 2006 AND AUGUST 2012, HAR WAS PERFORMED IN 75 CONSECUTIVE PATIENTS, WITH RETROSPECTIVE ANALYSIS OF A SUBGROUP OF 45 PATIENTS WHO UNDERWENT HAR WITH COMPLICATED ACUTE (N = 10), SUBACUTE (N = 7), OR CHRONIC (N = 28) TYPE B DISSECTION AS THE UNDERLYING DISEASE. DESCRIPTIVE STATISTICS WERE COMPUTED FOR CONTINUOUS AND CATEGORIC VARIABLES. THE INTERVAL TO DEATH OR LAST FOLLOW-UP WAS ESTIMATED USING THE KAPLAN-MEIER METHOD. RESULTS: THE PATIENTS WERE A MEAN AGE OF 59.9 ± 10.7 YEARS (MEDIAN, 59.2; RANGE, 35-78 YEARS). COMPLETE SUPRA-AORTIC DEBRANCHING WAS PERFORMED IN SIX (13%) IN ZONE 0 (PROCEDURE TIME, 200 MINUTES; RANGE, 185-365 MINUTES) AND PARTIAL DEBRANCHING IN 39 (87%), COMPRISING 16 (36%) IN ZONE 1 (PROCEDURE TIME, 120 MINUTES; RANGE, 75-250 MINUTES) AND 23 (51%) IN ZONE 2 (PROCEDURE TIME, 91 MINUTES; RANGE, 70-210 MINUTES). TECHNICAL SUCCESS WAS ACHIEVED IN 86.7% (39 OF 45). THIRTY-DAY MORTALITY WAS 4.4% (TWO OF 45), WITH AN IN-HOSPITAL MORTALITY OF 11.1% (FIVE OF 45) AS A RESULT OF THREE ADDITIONAL DEATHS AFTER DAYS 33, 35, AND 111. COMPARING HAR FOR TYPE B DISSECTION AFTER COMPLETE DEBRANCHING IN SIX AND PARTIAL DEBRANCHING IN 39, THE OVERALL IN-HOSPITAL MORTALITY WAS 67% (FOUR OF SIX) AND 2.6% (ONE OF 39), RESPECTIVELY. AFTER A MEDIAN FOLLOW-UP OF 20.8 MONTHS (RANGE, 0.3-70 MONTHS), THE OVERALL MORTALITY WAS 13.3% (SIX OF 45), WITH KAPLAN-MEIER SURVIVAL ESTIMATE OF 85% AT 1 YEAR. STROKE RATE WAS 8.8% (FOUR OF 45). PARAPLEGIA DEVELOPED IN ONE PATIENT (2.2%), WITH COMPLETE RECOVERY AFTER SPINAL DRAINAGE. CARDIAC COMPLICATIONS OCCURRED IN THREE PATIENTS (6.7%), PULMONARY COMPLICATIONS IN 10 (22.2%), AND RENAL INSUFFICIENCY REQUIRING DIALYSIS DEVELOPED IN FIVE (11%). RETROGRADE DISSECTION OCCURRED IN ONE PATIENT (2.2%) 14 DAYS AFTER COMPLETE DEBRANCHING AND ZONE 0 THORACIC ENDOVASCULAR AORTIC REPAIR, WITH FATAL OUTCOME. NO BYPASS DYSFUNCTION WAS SEEN DURING FOLLOW-UP. THE OVERALL EARLY AND LATE ENDOLEAK RATES WERE 27% (12 OF 44) AND 43% (13 OF 30), RESPECTIVELY. EIGHT PATIENTS (18%) REQUIRED REINTERVENTION, WITH FREEDOM OF REINTERVENTION IN 91% AT 1 YEAR AND 81% AT 2 YEARS. CONCLUSIONS: HAR IN ZONE 1 AND 2 APPEARS A VIABLE ALTERNATIVE TO CONVENTIONAL AORTIC ARCH SURGERY IN PATIENTS WITH COMPLICATED TYPE B DISSECTION. STROKE AND ENDOLEAKS REMAIN COMPLICATIONS THAT NEED TO BE ADDRESSED. TREATMENT OF TYPE B AORTIC DISSECTION WITH COMPLETE SUPRA-AORTIC DEBRANCHING AND THORACIC ENDOVASCULAR AORTIC REPAIR IN ZONE 0, HOWEVER, IS ASSOCIATED WITH HIGH MORTALITY, WHICH MIGHT BE REDUCED BY IMPROVED TECHNOLOGY USING BRANCHED STENT GRAFTS. (J VASC SURG 2013;58:1490-6.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118321 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Death| R