BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM

    MDR report key: 3024377 · Received March 27, 2013

    Report

    Report Number
    2953200-2013-00551
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 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

    (B)(4). EVALUATION RESULTS: (ENDOLEAK, INACCURATE DELIVERY OF STENT GRAFT). (SEVERELY ANGULATED AORTIC ARCH). (NOT OBSERVING THE FLUOROSCOPY DURING REMOVAL OF THE DELIVERY SYSTEM). (STENT GRAFT WAS IMPLANTED IN A PATIENT WITH A PRE-OPERATIVE DISSECTION OF THE THORACIC AORTA). CONCLUSION: (NOT OBSERVING THE FLUOROSCOPY DURING REMOVAL OF THE DELIVERY SYSTEM).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A DISSECTION WHICH EXTENDED FROM THE SUBCL AVIAN ARTERY TO 3 CM ABOVE THE CELIAC ARTERY APPROXIMATELY ONE MONTH AGO. THE THORACIC AORTIC NECK HAD A TIGHT ANGULATED ARCH. THE AORTA PROXIMAL LANDING ZONE JUST DISTAL TO THE LEFT SUBCLAVIAN ARTERY IS 26.2 MM IN DIAMETER, AND PROXIMAL TO THE DISSECTION IT IS 21.4MM IN DIAMETER. THE LENGTH OF THE PROXIMAL LANDING ZONE IS 23MM. THE STENT GRAFT WAS DEPLOYED AT THE INTENDED LANDING ZONE WITHOUT COMPLICATION; HOWEVER, UPON REMOVAL OF THE DELIVERY SYSTEM THE PHYSICIAN WAS RESEATING THE TAPERED TIP BUT WAS NOT WATCHING THE FLUOROSCOPY, WHICH RESULTED IN THE TAPER TIP BEING CAUGHT ON THE STENT GRAFT MATERIAL AND PULLED IT DOWN 3 CM. DUE TO THIS AND THE TIGHT AORTIC ARCH THE STENT GRAFT WAS INACCURATELY IMPLANTED AND THERE WAS A PROXIMAL TYPE I ENDOLEAK. ANOTHER VALIANT (B)(4) WAS IMPLANTED AND SUCCESSFULLY RESOLVED THE ENDOLEAK. NO CLINICAL SEQUELAE WERE REPORTED ANT THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126159 VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03021176

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention