BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX STENT GRAFT SYSTEM

    MDR report key: 5181937 · Received October 27, 2015

    Report

    Report Number
    2953200-2015-01829
    Event Type
    Death
    Date Received
    October 27, 2015
    Date of Event
    December 10, 2013
    Report Date
    October 6, 2015
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT DATE OF THE DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; STENT GRAFT PLACEMENT FOR A TRACHEOINNOMINATE ARTERY FISTULA. DOUGLAS A. TROUTMAN, MATTHEW J. DOUGHERTY, ADAM I. SPIVACK, AND KEITH D. CALLIGARO, (ANN VASC SURG 2014; 28: 1037.E21-1037.E24) HTTP://DX.DOI.ORG/10.1016/J.AVSG.2013.08.021 AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF 3.9 BY 3.6-CM PSEUDOANEURYSM OF THE INNOMINATE ARTERY. IT WAS REPORTED THAT THE PATIENT WAS SUCCESSFULLY TREATED WITH STENT GRAFT INSERTION VIA THE RIGHT COMMON CAROTID ARTERY, WITH EXCLUSION OF THE ANEURYSM FROM THE PROXIMAL INNOMINATE TO THE RIGHT COMMON CAROTID ARTERY, WITH LIGATION OF THE PROXIMAL RIGHT SUBCLAVIAN ARTERY AND RIGHT COMMON CAROTID TO SUBCLAVIAN ARTERY BYPASS. THE PATIENT REMAINED MEDICALLY STABLE FOR 3 MONTHS AFTER THE PROCEDURE WITH NO EVIDENCE OF ENDOLEAK OR INFECTION. THE PATIENT THEN DEVELOPED RECURRENT HEMOPTYSIS WITH FATAL CARDIAC ARREST. ON POSTOPERATIVE DAY 115, THE PATIENT DEVELOPED ABRUPT MASSIVE HEMOPTYSIS SECONDARY TO STENT GRAFT EROSION AND EXPIRED. A (B)(6) WOMAN WITH VENTILATOR-DEPENDENT RESPIRATORY FAILURE AND MULTIPLE COMORBIDITIES DEVELOPED ACUTE MASSIVE HEMOPTYSIS. COMPUTED TOMOGRAPHIC ANGIOGRAM REVEALED A 3.9-CM PSEUDOANEURYSM ARISING FROM THE INNOMINATE ARTERY ABUTTING THE TRACHEA. THE PATIENT WAS SUCCESSFULLY TREATED WITH STENT GRAFT INSERTION VIA THE RIGHT COMMON CAROTID ARTERY, WITH EXCLUSION OF THE ANEURYSM FROM THE PROXIMAL INNOMINATE TO THE RIGHT COMMON CAROTID ARTERY, WITH LIGATION OF THE PROXIMAL RIGHT SUBCLAVIAN ARTERY AND RIGHT COMMON CAROTID TO SUBCLAVIAN ARTERY BYPASS. THE PATIENT REMAINED MEDICALLY STABLE FOR 3 MONTHS AFTER THE PROCEDURE WITH NO EVIDENCE OF ENDOLEAK OR INFECTION. SHE THEN DEVELOPED RECURRENT HEMOPTYSIS WITH FATAL CARDIAC ARREST. OPEN SURGICAL REPAIR HAS BEEN THE TREATMENT OF CHOICE FOR TRACHEOINNOMINATE ARTERY FISTULA. HOWEVER, DIRECT REPAIR CONFERS A HIGH MORTALITY RISK. ENDOVASCULAR EXCLUSION OFFERS A LESS INVASIVE TREATMENT OPTION FOR TRACHEOINNOMINATE ARTERY FISTULA AND CAN SERVE AS A BRIDGE FOR PATIENTS WITH POTENTIAL FOR BECOMING BETTER SURGICAL CANDIDATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712046 ANEURX STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Death