BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM (CT)

    MDR report key: 1725443 · Received June 11, 2010

    Report

    Report Number
    2953200-2010-01126
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    May 14, 2010
    Report Date
    May 14, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    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): EVALUATION RESULTS: DEATH, ARTERIAL TRAUMA DISSECTION/PERFORATION. NARROW, DISEASED AORTA. CONCLUSION: NARROW, DISEASED AORTA.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT DEVICE WAS IMPLANTED INTO A PT FOR THE TREATMENT OF AN 11.2 CM LONG SACCULAR THORACIC AORTIC ANEURYSM AT ZONE 2. THE PROXIMAL NECK IS 35 MM IN DIAMETER; DISTAL NECK IS 29 MM IN DIAMETER. THERE WAS ALSO AN ABDOMINAL AORTIC ANEURYSM PRESENT, AND THE ABDOMINAL AORTA HAD THROMBUS/PLAQUE/ATHEROMA. THE VESSELS WERE NON-CALCIFIED AND NON-TORTUOUS BUT NARROW. IT WAS REPORTED THAT A LUNDERQUIST GUIDEWIRE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY FOLLOWED BY INSERTION OF THE FIRST TALENT THORACIC DEVICE; HOWEVER, DURING ATTEMPTS TO INSERT THE DEVICE INTO THE EXTERNAL ILIAC ARTERY, THE GRAFT COVER MOVED DISTALLY; THEN THE TAPERED TIP GOT PUSHED INTO THE GRAFT COVER WHICH RESULTED IN THE EDGE OF THE GRAFT COVER TO GET DAMAGED (SEE MFR # 2953200-2010-01125). THE PHYSICIAN STOPPED THE INSERTION OF THIS DEVICE AND CHOSE FEMORAL; HOWEVER, THIS WAS UNSUCCESSFUL DUE TO RESISTANCE. THE DEVICE WAS REMOVED FROM THE PT AND GRAFT COVER WAS FOUND DEFORMED, AND THERE WAS AN AVULSION/DISSECTION OF THE INTIMA. THE ACCESS ROUTE WAS CHANGED TO THE LEFT SIDE. THE GRAFT COVER WAS KINKED AND THE PHYSICIAN ELECTED TO STRAIGHTEN IT OUT, AND HE WAS ABLE TO SUCCESSFULLY INSERT IT INTO LEFT EXTERNAL ILIAC ARTERY. THE STENT GRAFT WAS IMPLANTED IN THE DISTAL PORTION OF THE ANEURYSM. A PROXIMAL TALENT THORACIC STENT GRAFT WAS IMPLANTED INTO THE DISTAL PORTION OF THE ANEURYSM UP TO THE OSTIUM OF LCCA AND COVERED THE LSA. A 20 FR SHEATH FROM ANOTHER MFR WAS INSERTED FOLLOWED BY THE USE OF A BALLOON FOR TOUCH-UP OF THE TALENT THORACIC STENT GRAFT. AFTER ANGIOGRAPHY WAS PERFORMED. THE LSA WAS OCCLUDED BY COILING AND THIS CONCLUDED THE TEVAR PROCEDURE. ATTENTION WAS DRAWN TOWARDS THE ABDOMINAL ANEURYSM AND FOR THE REPAIR OF DISSECTED RIGHT INTERNAL ARTERY. THE GUIDEWIRE WAS LEFT IN THE PT, AND THE SHEATH WAS EXCHANGED FOR AN 18 FR. ANGIOGRAPHY REVEALED OCCLUSION OF BOTH INTERNAL ILIAC ARTERIES. ANOTHER MFR'S DEVICE WAS IMPLANTED FOR TREATMENT OF THE ABDOMINAL ANEURYSM; HOWEVER, AFTER THE STENT GRAFT WAS IMPLANTED AND BALLOONING WAS PERFORMED, THE ANGIOGRAM REVEALED A PROXIMAL TYPE 1 ENDOLEAK. A PTA BALLOON WAS USED FOR TOUCH-UP, AND THE ENDOLEAK RESOLVED AND THE FLOW TO BOTH EXTERNAL ILIAC ARTERIES WAS CONFIRMED. THIS CONCLUDED THE EVAR. AFTER CLOSING THE ACCESS SITE, THE BLOOD PRESSURE OF LEFT LIMB DROPPED AND AN ANGIOGRAM OF THE LEIA WAS PERFORMED. AN EMBOLECTOMY WAS PERFORMED WITH A FOGARTY FOLLOWED BY IMPLANT OF A 10 MM PERIPHERAL STENT TO COVER THE LEIA. THE PRESSURE DID NOT ELEVATE; HOWEVER, THE PHYSICIAN DECIDED TO NOT FURTHER INTERVENE AND TO MONITOR THE PT. FOUR DAYS LATER, THE PT EXPIRED DUE TO BOWEL ISCHEMIA FROM A MESENTERIC ARTERIAL OCCLUSION (SEE MFR # 2953200-2010-01127). THE PHYSICIAN COMMENTED; HE WAS UNABLE TO PERFORM ANY TREATMENT DUE TO THE ISCHEMIA. THE REASON FOR THE ISCHEMIA IS UNDETERMINED, AND IT IS UNK WHICH PROCEDURE, THE TEVAR OR EVAR CAUSED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM (CT) MIH MEDTRONIC CARDIOVASCULAR NA V00313433

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death