BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 6766339 · Received August 4, 2017

    Report

    Report Number
    2953200-2017-01236
    Event Type
    Injury
    Date Received
    August 4, 2017
    Date of Event
    July 31, 2015
    Report Date
    July 12, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE TITLE: CLINICAL FEATURES AND PROGNOSTIC VALUE OF STENT-GRAFT-INDUCED POST-IMPLANTATION SYNDROME AFTER THORACIC ENDOV ASCULAR AORTIC REPAIR IN PATIENTS WITH TYPE B ACUTE AORTIC SYNDROMES RICCARDO GORLA, RAIMUND ERBEL, PHILIPP KAHLERT, KONSTANTINOS TSAGAKIS, HEINZ JAKOB, AMIR- ABBAS MAHABADI, THOMAS SCHLOSSER, KIM EAGLE, EDUARDO BOSSONE AND ROLF ALEXANDER JÁNOSI EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 49 (2016) 1239¿1247 ORIGINAL ARTICLE DOI:10.1093/EJCTS/EZV355.

    Description of Event or Problem · 1

    TALENT AND VALIANT STENT GRAFT SYSTEMS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR BETWEEN 2002 AND 2014. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: POST-IMPLANTATION SYNDROME, FEVER, MULTIORGAN FAILURE, AORTIC RUPTURE, CARDIAC COMPLICATIONS, INFECTION, STROKE, TYPE IA ENDOLEAK, NEW DISSECTION, AORTIC ENLARGEMENT, DEATH ABSTRACT OBJECTIVES: THE AIM OF THIS STUDY WAS TO INVESTIGATE THE INCIDENCE, THE BIOMARKER PROFILE AND THE CLINICAL IMPACT OF POST-IMPLANTATION SYNDROME (PIS) AFTER THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) FOR TYPE B ACUTE AORTIC SYNDROMES (AASS). METHODS: THIS RETROSPECTIVE STUDY INCLUDED 133 PATIENTS WITH TYPE B AASS UNDERGOING TEVAR; PIS WAS DEFINED AS FEVER >38°C, WHITE BLOOD CELLS (WBCS) >12.0/NL AND C-REACTIVE PROTEIN (CRP) >10 MG/DL WITHIN 72 H AFTER TEVAR, DESPITE NEGATIVE BLOOD CULTURES. FIBRINOGEN (FBG), D-DIMER (D-D) AND INTERLEUKIN 6 (IL-6) WERE ALSO DETERMINED. THE CLINICAL ENDPOINTS WERE ALL-CAUSE MORTALITY AND A COMPOSITE OF MAJOR ADVERSE EVENTS (MAES SUCH AS AORTIC RUPTURE, NEED FOR REINTERVENTION AND ALL-CAUSE MORTALITY) AT FOLLOW-UP. RESULTS: PIS WAS DIAGNOSED IN 15.8% OF PATIENTS AND WAS ASSOCIATED WITH HIGHER PEAK VALUES OF WBC (17.0 ± 5.1 VS 10.6 ± 3.7/NL, P = 0.002), CRP (22.0 ± 5.4 VS 16.8 ± 8.2 MG/DL, P = 0.03), FBG (779 ± 246 VS 639 ± 225 MG/DL, P = 0.046), D-D (1675 ± 605 VS 1048 ± 639 ¿G/L, P = 0.003) AND IL-6 (192 ± 101 VS 84 ± 34 PG/ML, P = 0.03) THAN NON-PIS PATIENTS. ALL-CAUSE MORTALITY DID NOT SIGNIFICANTLY DIFFER BETWEEN PIS AND NON-PIS PATIENTS DURING THE INDEX HOSPITALIZATION (0.0 VS 6.3%; P = 0.60) AND AT FOLLOW-UP (18.8 VS 4.9%; P = 0.086). MAES WERE MORE FREQUENT IN THE PIS THAN IN THE NON-PIS GROUP (62.5 VS 25.9%; P = 0.004). PIS (HAZARD RATIO [HR] 3.26, P = 0.022), STROKE (HR 3.41, P = 0.004), AORTIC ENLARGEMENT (HR 6.88, P = 0.001) AND PARTIAL THROMBOSIS OF THE FALSE LUMEN (HR 6.20, P = 0.003) WERE INDEPENDENT PREDICTORS OF MAES. CONCLUSIONS: PIS OCCURRED IN 15.8% OF PATIENTS WITH AASS WITHOUT AFFECTINGIN-HOSPITAL OUTCOME. AT FOLLOW-UP, PIS WAS ASSOCIATED WITH INCREASED RATES OF MAES, BUT NOT MORTALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547810 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention