BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4496292 · Received February 9, 2015

    Report

    Report Number
    2953200-2015-00240
    Event Type
    Injury
    Date Received
    February 9, 2015
    Date of Event
    January 14, 2014
    Report Date
    January 15, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    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; CRYOPRESERVED AORTIC HOMOGRAFT FOR IN SITU REPLACEMENT OF INFECTED THORACIC STENT GRAFT ASSOCIATED WITH DISTAL AORTIC ARCH RUPTURE AND HEMATEMESIS. MLADEN PETRUNI_C, MD, PHD, BOJAN BIO_CINA, MD, PHD, SANDRA UZUN, MD, TOMISLAV ME_STROVI_C, MD, AND IVICA _SAFRADIN, MD. ANN THORAC SURG 2014;98:2219¿21) A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC REPAIR. DURING THE RETROSPECTIVE STUDY THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: INFECTION, POST-OPERATIVE RUPTURE, HEMATEMESIS, OPEN REPAIR, REMOVAL OF IMPLANT. ENDOGRAFT INFECTIONS PRESENT A POTENTIALLY LETHAL COMPLICATION OF THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). WE REPORT A CASE OF A YOUNG MALE PATIENT WHO WAS REFERRED TO OUR INSTITUTION BECAUSE OF A STENT GRAFT INFECTION THAT OCCURRED 10 MONTHS AFTER TEVAR. CONTAINED DISTAL AORTIC ARCH RUPTURE AND HEMATEMESIS WERE ASSOCIATED WITH THE ENDOGRAFT INFECTION. EMERGENT OPEN SURGICAL REPAIR WAS UNDERTAKEN WITH DEEP HYPOTHERMIC CIRCULATORY ARREST. AFTER THE REMOVAL OF THE INFECTED ENDOGRAFT, THE DISTAL AORTIC ARCH AND PROXIMAL DESCENDING THORACIC AORTA WERE REPLACED WITH A CRYOPRESERVED AORTIC HOMOGRAFT. FIFTEEN MONTH FOLLOW-UP WAS UNEVENTFUL. WE DISCUSS TECHNIQUES AND MATERIALS FOR REPLACEMENT OF THE INFECTED ENDOGRAFT. THE ARTICLE PROVIDES AN OUTLINE OF THE POTENTIAL BENEFIT OF CRYOPRESERVED AORTIC HOMOGRAFTS WITHIN THE SETTING OF A COMPLEX THORACIC AORTIC INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90116 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 YR Required Intervention