BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2130006 · Received June 10, 2011

    Report

    Report Number
    2953200-2011-01120
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (OCCLUSION, MISPLACEMENT OF THE DEVICE). (CARDIAC ARREST). CONCLUSIONS: (CARDIAC ARREST).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR ANEURYSM 5.3 CM X 6.8 CM THORACIC AORTIC ANEURYSM AT ZONE THREE APPROXIMATELY ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS NO CALCIFICATION OR THROMBUS AND A PROXIMAL THORACIC AORTIC NECK OF 34 MM NO CALCIFICATION OR THROMBUS. IT WAS REPORTED THAT CARDIAC ARREST WAS INDUCED WITH ADENOSINE TRIPHOSPHATE. THE PHYSICIAN STARTED TO DEPLOY THE (B)(4) UNTIL TWO STENT RINGS WERE DEPLOYED AND NOTED THAT A BARE SPRING WAS TURNED OVER. (REF MFR#2953200-2011-01120). THE PHYSICIAN RESOLVED THIS BY PULLING DOWN THE DELIVERY SYSTEM, HOWEVER, THE BARE SPRING THEN OPENED IN THE ANEURYSM. AN ADDITIONAL STENT GRAFT (B)(4) (REF MFR#2953200-2011-01121) WAS REQUIRED TO COVER THE PROXIMAL PORTION OF THE ANEURYSM. WHEN THE PHYSICIAN PULLED THIS STENT GRAFT TO POSITION IT ACCURATELY, IT CAUGHT ON THE FIRST STENT GRAFT, AND THE STENT GRAFT WAS DISCONNECTED FROM THE DELIVERY SYSTEM. THE SECOND STENT GRAFT THEN COVERED THE BRACHIOCEPHALIC ARTERY AND THE LEFT COMMON CAROTID ARTERY; HOWEVER, BLOOD FLOW WAS MAINTAINED. THE PHYSICIAN ADJUSTED THE STENT GRAFT POSITIONING WITH A BALLOON AND THE BRACHIOCEPHALIC ARTERY WAS OPENED. THE LEFT COMMON CAROTID ARTERY WAS STILL COVERED, SO THE PHYSICIAN PLACED A STENT TO ESTABLISH BLOOD FLOW. THE ENDOLEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WER REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00822533

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention