BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM

    MDR report key: 3020037 · Received March 25, 2013

    Report

    Report Number
    2953200-2013-00524
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK. LACK OF INFORMATION (UNKNOWN CAUSE OF ENDOLEAK). CONCLUSION: LACK OF INFORMATION (UNKNOWN CAUSE OF ENDOLEAK).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM APPROXIMATELY THREE MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT WAS IN FOR A ROUTINE FOLLOW-UP APPOINTMENT AND IT WAS NOTED THAT THERE WAS A PROXIMAL TYPE I ENDOLEAK. ANOTHER MANUFACTURER'S 26 FR SHEATH WAS INSERTED TO THE JUNCTION OF THE COMMON ILIAC AND EXTERNAL ILIAC ARTERY. AN ATTEMPT TO INSERT A VALIANT STENT GRAFT WAS NOT SUCCESSFUL; THEREFORE, THE SHEATH WAS REMOVED. THE VALIANT STENT GRAFT WAS RE-INSERTED AND THE STENT GRAFT WAS DEPLOYED SUCCESSFULLY. THE STENT GRAFT WAS BALLOONED WITH ANOTHER MANUFACTURER'S BALLOON. AN ANGIOGRAM WAS DONE AND THE TYPE I ENDOLEAK HAD NOT RESOLVED. UPON REMOVAL OF THE SHEATH THE ILIAC ARTERY TORE. AN I-CAST STENT AND ANOTHER MANUFACTURER'S STENT WERE IMPLANTED. THE PATIENT WAS GIVEN BLOOD PRODUCTS DURING THE PROCEDURE. THE PATIENT WILL BE MONITORED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS STABLE.

    Description of Event or Problem · 1

    A REVIEW OF RETURNED 3D PLANNING WORKSHEET POST-IMPLANT SHOW THAT THE DEVICE WAS POSITIONED JUST DISTAL TO THE LSA. THE CAUSE OF THE REPORTED TYPE I ENDOLEAK COULD NOT BE DETERMINED FROM THESE IMAGES. IT IS POSSIBLE THAT THERE WAS INSUFFICIENT PROXIMAL SEALING LENGTH. IMAGES AT THE ORIGINAL IMPLANT, AND DURING THE SECONDARY IMPLANT, WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121874 VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01103077

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention