BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4703069 · Received April 17, 2015

    Report

    Report Number
    2953200-2015-00737
    Event Type
    Injury
    Date Received
    April 17, 2015
    Date of Event
    January 17, 2014
    Report Date
    March 31, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; COMBINED ENDOVASCULAR AND SURGICAL APPROACH FOR AORTOBRONCHIAL FISTULA. LUDOVIC CANAUD, MD, PHD, THOMAS D¿ANNOVILLE, MD, BARIS ATA OZDEMIR, FRCS, CHARLES MARTY-AN_E, MD, PHD, AND PIERRE ALRIC, MD, PHD. (J THORAC CARDIOVASC SURG 2014;148:2108-11) A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTOBRONCHIAL FISTULA. DURING THE RETROSPECTIVE STUDY THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE I AND TYPE II ENDOLEAK, SURGICAL CONVERSION. OBJECTIVE: THE PERIOPERATIVE OUTCOMES OF THE ENDOVASCULAR APPROACH TO AORTOBRONCHIAL FISTULA HAVE BEEN FAVORABLE. HOWEVER, IT IS UNCERTAIN WHETHER THORACIC ENDOVASCULAR ANEURYSM REPAIR (TEVAR) ALONE PROVIDES A COMPLETE AND DURABLE CURE FOR AN AORTOBRONCHIAL FISTULA. TEVAR DOES NOTHING TO ADDRESS THE ISSUE OF THE DEFECT IN THE RESPIRATORY TRACT, LEAVING THE PATIENT AT RISK OF AORTOBRONCHIAL FISTULA RECURRENCE AND/OR STENT GRAFT INFECTION. THE AUTHORS BELIEVE THAT THE BRONCHIAL DEFECT SHOULD BE ADDRESSED. METHODS: OVER THE LAST 10 YEARS, 5 PATIENTS WERE TREATED FOR AN AORTOBRONCHIAL FISTULA USING A COMBINED ENDOVASCULAR AND SURGICAL APPROACH (PRIMARY TREATMENT IN 3 PATIENTS AND SECONDARY AFTER TEVAR IN 2 PATIENTS). ALL THE PATIENTS UNDERWENT EMERGENCY STENT GRAFT PLACEMENT AND CONCOMITANT (N ¼ 1) OR STAGED (N ¼ 4) OPEN REPAIR INCLUDING PULMONARY RESECTION WITH COVERAGE OF THE STENT GRAFT USING MUSCLE OR PLEURAL FLAPS. ALL PATIENTS RECEIVED A 6-WEEK COURSE OF BROAD-SPECTRUM INTRAVENOUS ANTIBIOTICS FOLLOWED BY LIFELONG ORAL ANTIBIOTICS. RESULTS: ALL PATIENTS SURVIVED THE SURGICAL PROCEDURE. AFTER A MEAN FOLLOW-UP OF 23.2 MONTHS, 4 PATIENTS ARE ASYMPTOMATIC AND POSTPROCEDURE COMPUTED TOMOGRAPHY SCANS WERE UNREMARKABLE. ONE PATIENT TREATED FOR AN AORTOBRONCHIAL FISTULA AFTER TEVAR WAS READMITTED 4 MONTHS AFTER SURGICAL CONVERSION. STENT GRAFT EXPLANTATION AND SILVER-COATED TUBE GRAFT REPLACEMENT OF THE DESCENDING THORACIC AORTA WERE PERFORMED FOR SEVERE MEDIASTINITIS WITH ASSOCIATED THORACIC STENT GRAFT INFECTION. THE POSTOPERATIVE COURSE OF THIS PATIENT WAS UNEVENTFUL. CONCLUSIONS: EMERGENCY TEVAR FOR AN AORTOBRONCHIAL FISTULA IS AN APPEALING STRATEGY FOR THIS DEVASTATING COMPLICATION. HOWEVER, TO ACHIEVE A LASTING RESULT, DIRECT CONTACT BETWEEN THE STENT GRAFT AND THE PULMONARY TISSUE SHOULD BE AVOIDED TO PREVENT FURTHER EROSIVE DAMAGE. CONCOMITANT OR STAGED REPAIR SHOULD ENTAIL PRIMARY REPAIR OR RESECTION AND ANASTOMOSIS OF THE BRONCHUS AND/OR PULMONARY RE SECTION WITH COVERAGE OF THE STENT GRAFT USING MUSCLE OR PLEURAL FLAPS COMBINED WITH BROAD-SPECTRUM INTRAVENOUS ANTIBIOTIC THERAPY. LONG-TERM SURVEILLANCE AND CONTINUED INVESTIGATION ARE WARRANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256972 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention