BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 3625587 · Received February 12, 2014

    Report

    Report Number
    2953200-2014-00251
    Event Type
    Injury
    Date Received
    February 12, 2014
    Date of Event
    July 4, 2013
    Report Date
    January 16, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS, CONCLUSION: AORTOESOPHAGEAL FISTULA, BOERHAAVE SYNDROME; AORTOESOPHAGEAL FISTULA, PRE-OPERATIVE RUPTURE; INFECTION.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. STRATEGIES FOR ENDOVASCULAR AORTIC REPAIR IN AORTOBRONCHIAL AND AORTOESOPHAGEAL FISTULAS. DORWEILER B, WEIGANG E, DUENSCHEDE F, PITTON MB, DUEBER C, VAHL CF. (J VASC SURG 2011). DOI:10.1016/J.JVS.2011.05.020 PATIENT RECEIVED VISCERAL DEBRANCHING IMMEDIATELY AFTER TEVAR. PATIENT WAS READMITTED 3 MONTHS AFTER INDEX PROCEDURE DUE TO DILATATION OF A STENOSIS OF THE ESOPHAGOGASTRIC ANASTOMOSIS REPEATEDLY. PATIENT REQUIRED A PROXIMAL GRAFT EXTENSION./ PREEXISTING COMORBIDITIES INCLUDED: RUPTURED MYCOTIC ANEURYSM OF DISTAL THORACIC AORTA DUE TO BOERHAAVE SYNDROME WITH ESOPHAGEAL PERFORATION. BRONCHIAL LAVAGES/DRAINAGE SPECIMEN REVEALED GRAM-POSITIVE BACTERIA AND CANDIDA SPECIES, WHICH REQUIRED TREATMENT WITH ANTIBIOTICS. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. OBJECTIVE: TO REPORT OUR EXPERIENCE OF THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) FOR ACUTE BLEEDING ORIGINATING FROM THE THORACIC AORTA IN PATIENTS WITH AORTOBRONCHIAL FISTULA (ABF) OR AORTOESOPHAGEAL FISTULA (AEF). PATIENTS AND METHODS: A TOTAL OF NINE PATIENTS (THREE WOMAN) WERE TREATED FROM SEPTEMBER 1995 TO MARCH 2012 BY TEVAR FOR ABF (N = 5) AND AEF (N = 4). THE IMPLANTS (N = 14) WERE INTRODUCED WITH FLUOROSCOPIC GUIDANCE VIA THE AORTA (N = 1), THE ILIAC (N = 2), OR FEMORAL (N = 11) ARTERY, RESPECTIVELY. RESULTS: ALL AORTIC LESIONS COULD BE SEALED SUCCESSFULLY. PERIOPERATIVE MORBIDITY WAS 0% IN THE ABF GROUP AND 50% (2 OF 4) IN THE AEF GROUP AND NO PROCEDURE-RELATED MORBIDITY WAS NOTED EXCEPT ONE PATIENT WHO RECEIVED AORTOFEMORAL RECONSTRUCTION BECAUSE OF ILIAC OCCLUSIVE DISEASE. AFTER AN OVERALL MEAN FOLLOW-UP OF 56 MONTHS, THREE PATIENTS OF THE ABF GROUP ARE ALIVE AND WELL AND TWO PATIENTS DIED OF NONRELATED CAUSE. OF THE AEF GROUP, ONE PATIENT IS ALIVE AFTER 22 MONTHS, AND ONE DIED FROM METASTASIZED ESOPHAGEAL CANCER AFTER 7 MONTHS. CONCLUSION: TEVAR IS A SAFE AND RELIABLE PROCEDURE IN THE MANAGEMENT OF ABF. FOR AEF, TEVAR PROVIDES A SUCCESSFUL FIRST-LINE TREATMENT TO SEAL THE FISTULA AND CONTROL BLEEDING. HOWEVER, PROGNOSIS IS LIMITED BY THE ESOPHAGEAL LESION AND BY ONGOING MEDIASTINITIS/SEPSIS. NOT TREATING ON-LABEL INDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92784 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention