BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 4177435 · Received October 16, 2014

    Report

    Report Number
    2953200-2014-02090
    Event Type
    Injury
    Date Received
    October 16, 2014
    Date of Event
    December 6, 2013
    Report Date
    September 24, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CONCLUSION: OFF-LABEL (MARFANS SYNDROME).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. ENDOVASCULAR THERAPY IN PATIENTS WITH GENETICALLY TRIGGERED THORACIC AORTIC DISEASE: APPLICATIONS AND SHORT- AND MID-TERM OUTCOMES. OURANIA PREVENTZA, SOMALA MOHAMMED, BENJAMIN Y. CHEONG, LORENA GONZALEZ, MARAL OUZOUNIAN, JAMES J. LIVESAY, DENTON A. COOLEY AND JOSEPH S. COSELLI (EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 2014; 46(2):248-53.) ON UNKNOWN DATES BETWEEN (B)(6) 2003 TO (B)(6) 2013, A VALIANT AND TALENT STENT GRAFT WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF DISSECTIONS AND ANEURYSMS. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DYSPNEA, PARALYSIS STROKE, RENAL FAILURE, ENDOLEAKS, ISCHEMIA, DISSECTION, MULIT-ORGAN FAILURE. OBJECTIVE: FOR PATIENTS WITH GENETICALLY TRIGGERED THORACIC AORTIC DISEASE, THE MORBIDITY AND MORTALITY ASSOCIATED WITH REOPERATION ARE HIGH, MAKING ENDOVASCULAR TREATMENT AN APPEALING OPTION. WE EVALUATED THE SHORT- AND MID-TERM OUTCOMES OF DIFFERENT APPLICATIONS OF ENDOVASCULAR INTERVENTION IN SUCH PATIENTS. METHODS: BETWEEN (B)(6) 2003 AND (B)(6) 2013, 60 PATIENTS RECEIVED ENDOVASCULAR OR HYBRID TREATMENT FOR GENETICALLY TRIGGERED THORACIC AORTIC DISEASE. THE INCLUSION CRITERIA WERE BASED ON THOSE DEVISED BY THE NATIONAL REGISTRY OF GENETICALLY TRIGGERED THORACIC AORTIC ANEURYSMS AND CARDIOVASCULAR CONDITIONS. WE INCLUDED PATIENTS WITH THORACIC ANEURYSM OR DISSECTION NOT DUE TO TRAUMA IN A PATIENT AGED =50 YEARS (N = 30), BICUSPID AORTIC VALVE (BAV) AND COARCTATION (N = 11), MARFAN SYNDROME (N = 10), BAV WITH THORACIC ANEURYSM (N = 4), LOEYS¿DIETZ SYNDROME (N = 3), FAMILIAL THORACIC ANEURYSM OR DISSECTION (N = 3) AND GENETIC MUTATIONS (N = 2). SOME PATIENTS MET MORE THAN ONE INCLUSION CRITERION. FORTY-ONE (68.3%) PATIENTS WERE TREATED WITH ONLY ENDOVASCULAR STENT GRAFTING. NINETEEN (31.7%) PATIENTS UNDERWENT A HYBRID PROCEDURE WITH OPEN PROXIMAL OR TOTAL ARCH REPLACEMENT AND CONCOMITANT ENDOVASCULAR STENTING OF THE AORTIC ARCH OR THE DESCENDING THORACIC AORTA. TWENTY-NINE (48.3%) HAD PREVIOUS CARDIOVASCULAR OPERATIONS (MEAN ± SD, 1.9 ± 1.4) BEFORE UNDERGOING HYBRID OR ENDOVASCULAR THERAPY. THE MEDIAN FOLLOW-UP WAS 2.3 YEARS (INTERQUARTILE INTERVAL 25¿75%, 1.4¿4.6 YEARS). RESULTS: THE TECHNICAL SUCCESS RATE WAS 100%. IN-HOSPITAL MORTALITY WAS 3.3% (N = 2) AND NEUROLOGICAL EVENTS OCCURRED IN 2 PATIENTS; 1 (1.6%) HAD A STROKE AND 1 (1.6%) SUFFERED PARAPARESIS WITH PARTIAL RECOVERY. FIFTEEN REPEAT OPEN OR ENDOVASCULAR INTERVENTIONS WERE REQUIRED IN 10 SURVIVING PATIENTS (17.2%). OVERALL SURVIVAL DURING FOLLOW-UP WAS 94.8% (55/58). CONCLUSIONS: ENDOVASCULAR TECHNOLOGY CAN BE HELPFUL IN TREATING SELECTED YOUNG PATIENTS WITH GENETICALLY TRIGGERED THORACIC AORTIC DISEASE. LONG-TERM STUDIES AND FURTHER EVOLUTION OF ENDOVASCULAR TECHNOLOGY WILL BE NECESSARY FOR IT TO BE INCORPORATED INTO THE ARMAMENTARIUM OF SURGICAL OPTIONS FOR THIS CHALLENGING PATIENT POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658987 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention