BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX ADVANTAGE AORTIC EXTENDER CUFF

    MDR report key: 2040852 · Received March 30, 2011

    Report

    Report Number
    2953200-2011-00722
    Event Type
    Death
    Date Received
    March 30, 2011
    Date of Event
    March 1, 2011
    Report Date
    February 28, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: DEATH. CONCLUSION: PRE-OP DISSECTION. INSERTION OF THE DEVICE THROUGH THE VENTRICLE, USE IN PRE-OP DISSECTION.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION AND ANEURYSM, SEVEN WEEKS AGO. VESSEL MORPHOLOGY WAS REPORTED AS A VERY STEEP AORTIC ARCH. IT WAS REPORTED THAT THE PHYSICIAN INSERTED AND ATTEMPTED TO ADVANCE THE DELIVERY CATHETER THROUGH THE GROIN; HOWEVER, WAS UNABLE TO GAIN ACCESS. THE PT WAS BROUGHT BACK FOUR WEEKS AGO, TO IMPLANT A TALENT THORACIC GRAFT THAT THE PHYSICIAN HAD FENESTRATED WITH AN OPENING FOR THE INNOMINATE ARTERY AND RELOADED INTO THE DELIVERY SYSTEM. A WIRE WAS INSERTED THROUGH THE RIGHT CAROTID AND INNOMINATE ARTERIES. THE DELIVERY SYSTEM WAS PASSED VIA THE LEFT VENTRICLE AND THE ASCENDING AORTA. WHEN THE DELIVERY SYSTEM WAS IN THE ASCENDING AORTA, THE PHYSICIAN PUSHED HARD ENOUGH TO KINK THE GRAFT PLUNGER. THE PHYSICIAN FELT A CHANGE IN THE RESISTANCE TO THE DELIVERY SYSTEM, AND THE PT'S HEART BEGAN ATRIAL FIBRILLATION. AN ECHOGRAM WAS TAKEN AND SHOWED SOME DAMAGE TO PAPILLARY MUSCLE, AND THE MITRAL VALVE. THE PHYSICIAN THOUGHT THE DAMAGE MAY HAVE RESULTED FROM THE FORCE USED IN ADVANCING THE DELIVERY CATHETER. THE FLUOROSCOPY DEVICE STOPPED WORKING FOR ABOUT TEN MINUTES AT THIS TIME ALSO. THE DELIVERY CATHETER WAS THEN REMOVED FROM THE PT. THERE WERE SEVERAL MINUTES WHEN THE PT DID NOT HAVE BLOOD FLOW TO THE BRAIN. THE PT'S HEART WAS SHOCKED AND THE PT SUBSEQUENTLY STABILIZED. A BUDDY WIRE WAS ADVANCED THROUGH THE VENTRICLE AND THROUGH THE AORTIC ARCH, AND THE STENT GRAFT WAS DEPLOYED. (REF MFR #2953200-2011-00721). A CUFF WAS THEN IMPLANTED IN THE INNOMINATE ARTERY TO CONNECT TO THE FENESTRATED PORTION OF THE THORACIC STENT GRAFT. THE PT WAS PUT ON A BYPASS MACHINE AND TRANSFERRED TO ICU. THE PT WAS GIVEN ECOMOL TO INDUCE SEDATION BECAUSE OF THE MUSCLE DAMAGE. THE PT EXPIRED THE FOLLOWING DAY, WHEN AT THE FAMILY'S REQUEST, THE BREATHING TUBE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ADVANTAGE AORTIC EXTENDER CUFF MIH MEDTRONIC IRELAND NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death