BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 3790865 · Received May 5, 2014

    Report

    Report Number
    2953200-2014-00926
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 10, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: MEASUREMENT OF ILIAC LIMBS WAS NOT PERFORMED.

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF A 3-4CM FOCAL LESION THORACIC ULCER. IT WAS REPORTED THAT PRIOR TO INSERTION OF THE STENT GRAFT DELIVERY SYSTEM IT WAS NOTED THAT THE ACCESS VESSELS HAD NOT BEEN SIZED/EVALUATED. NO PELVIC CT IMAGING WAS DONE PRE CASE. PRE CASE ANGIOGRAM WAS THEN PERFORMED WHICH WAS NOTED BY VISUAL INSPECTION TO HAVE SMALL ACCESS VESSELS (SIZE NOT OFFICIALLY MEASURED). IT WAS DECIDED BY THE PHYSICIAN TO ATTEMPT IMPLANT. THE DELIVERY CATHETER WAS FLUSHED AND HYDROPHILIC COATING ACTIVATED IN USUAL FASHION. THE PHYSICIAN INSERTED THE DEVICE OVER A 260 WIRE IN THE USUAL FASHION. THE PHYSICIAN WAS UNABLE TO ADVANCE THE DELIVERY CATHETER TO THE INTENDED LANDING ZONE. TWO OR THREE ATTEMPTS WERE MADE TO PULL THE DELIVERY SYSTEM BACK AND RE-ADVANCE WITHOUT ANY SUCCESS. THE PHYSICIAN DECIDED NOT TO PROCEED AND REMOVED DELIVERY SYSTEM FROM THE WIRE. AT THAT POINT IT WAS NOTED THAT A DISSECTION OF THE COMMON FEMORAL ARTERY WAS NOTED. THIS WAS SUCCESSFULLY SURGICALLY REPAIRED AT THE CONCLUSION OF THE CASE AND THE PATIENT WAS SENT TO RECOVER IN STABLE CONDITION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED AND THE ANALYSIS HAS BEEN COMPLETED. THE EVENT WAS NOT CONFIRMED SINCE IT TOOK PLACE IN-VIVO. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, WAS MOST LIKELY DUE TO PATIENT ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266405 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04224790

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention