BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM

    MDR report key: 3020054 · Received March 25, 2013

    Report

    Report Number
    2953200-2013-00538
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: (FILMS).

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: SEVERELY ANGULATED AORTIC ARCH, PRE-OPERATIVELY DISSECTED THORACIC AORTA. STENT GRAFT WAS USED FOR TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY DISSECTED THORACIC AORTA. CONCLUSIONS: SEVERELY ANGULATED AORTIC ARCH PRE-OPERATIVELY DISSECTED THORACIC AORTA. STENT GRAFT WAS USED FOR TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY DISSECTED THORACIC AORTA.

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED EMERGENTLY IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM AND DISSECTION THAT WENT FROM THE SUBCLAVIAN ARTERY TO THE CELIAC ARTERY. A CAROTID TO SUBCLAVIAN ARTERY BYPASS WAS PERFORMED PRIOR TO STENT GRAFT IMPLANT. THE PHYSICIAN PLANNED TO COVER THE SUBCLAVIAN ARTERY AS PART OF THE PROCEDURE. THE AORTA ARCH HAD A SEVERE CURVE. THE FIRST STENT GRAFT WAS DEPLOYED AT THE INTENDED LANDING ZONE; HOWEVER, UPON REMOVAL OF THE DELIVERY SYSTEM THE TAPERED TIP GOT CAUGHT ON THE STENT GRAFT MATERIAL AND PULLED THE STENT GRAFT DISTALLY 2 CM AND THIS WAS ATTRIBUTED TO THE CURVE OF THE AORTIC ARCH AND THERE WAS A PROXIMAL TYPE I ENDOLEAK. ANOTHER VALIANT STENT GRAFT WAS INSERTED BUT IT WAS NOT POSSIBLE TO ADVANCE THE DELIVERY SYSTEM TO THE INTENDED LANDING ZONE DUE TO THE TIGHT ANGLE OF THE AORTIC ARCH. THE PHYSICIAN PULLED THE DELIVERY SYSTEM DOWN AND IMPLANTED THE STENT GRAFT DISTAL TO THE PREVIOUSLY DEPLOYED VALIANT STENT GRAFT. ANOTHER MANUFACTURER'S 45 MM DIAMETER STENT GRAFT WAS IMPLANT PROXIMAL TO THE FIRST IMPLANT STENT GRAFT AND SUCCESSFULLY RESOLVED THE TYPE I ENDOLEAK. ANOTHER VALIANT STENT GRAFT WAS IMPLANTED BETWEEN THE TWO VALIANT STENT GRAFTS AS PROPHYLACTIC MEASURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    FILMS WERE RECEIVED AND THEIR EVALUATION WAS COMPLETED. SEVERAL STILL ANGIOGRAM IMAGES AT IMPLANT WERE REVIEWED. AN ANGULATED THORACIC ARCH IS VERIFIED. THE REPORTED PRE-IMPLANT DISSECTION AND INTRAOPERATIVE PROXIMAL TYPE I ENDOLEAK COULD NOT BE SEEN IN THE IMAGES, AND IMAGES DURING THE REPORTED REMOVAL DIFFICULTIES WERE ALSO NOT SEEN ON THE PROVIDED FILMS. FINAL ANGIO SHOWS THAT THE STENT GRAFTS WERE PLACED FROM JUST PROXIMAL TO THE LSA, AND DISTALLY TO THE STRAIGHT SECTION OF THE DESCENDING THORACIC. NO STENT GRAFT ISSUES WERE SEEN ON THESE IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121899 VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01103079

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention