BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANT BALLOON

    MDR report key: 3011668 · Received March 19, 2013

    Report

    Report Number
    2953200-2013-00484
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K050038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ARTERIAL TRAUMA/DISSECTION/PERFORATION. PRE-OPERATIVELY DISSECTED THORACIC AORTA. STENT GRAFT WAS USED FOR TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY DISSECTED THORACIC AORTA. CONCLUSIONS: 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 WITH A CHRONIC DISSECTION APPROXIMATELY THREE WEEKS AGO. IT WAS REPORTED THAT AFTER MODELING THE PROXIMAL MOST SENT GRAFT WITH A RELIANT BALLOON THE FALSE LUMEN CONTINUED TO FILL. THE PHYSICIAN THEN IMPLANTED ANOTHER VALIANT STENT GRAFT PROXIMAL TO THE FIRST STENT GRAFT AND THE FINAL ANGIO SHOWED THE FALSE LUMEN WAS NO LONGER FILLING. THREE DAYS POST IMPLANT THE PATIENT DEVELOPED AN ANTEGRADE DISSECTION WHICH EXTENDED FROM THE LEFT SUBCLAVIAN TO THE ILIAC ARTERIES. THE TWO MOST PROXIMAL STENTS WHICH WERE DEPLOYED TO THE LEVEL OF THE LEFT CAROTID ARTERY REQUIRED SURGICAL REPAIR OF THE ASCENDING THORACIC AORTA. THE PHYSICIAN STATED THAT THE TYPE A DISSECTION WAS LIKELY CAUSED BY THE STENT GRAFT MODELING WITH THE RELIANT BALLOON. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114013 RELIANT BALLOON CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention