BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT AAA

    MDR report key: 3964559 · Received July 29, 2014

    Report

    Report Number
    2953200-2014-01474
    Event Type
    Death
    Date Received
    July 29, 2014
    Date of Event
    January 30, 2015
    Report Date
    February 1, 2015
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED 8 CM IN DIAMETER ANEURYSM. THE PHYSICIAN MADE NO SUCH STATEMENT REGARDING DEVICE OR PROCEDURE RELATIONSHIP. THE PHYSICIAN CONTINUED TO MONITOR THE PATIENT, HOWEVER THE PATIENT¿S CARE WAS WITHDRAWN AND THE PATIENT EXPIRED. THE PHYSICIAN STATED THAT THE PATIENT¿S CONDITION AND BLOOD LOSS CAUSED DEATH. FILM REVIEW WAS COMPLETED. CTA¿S FROM 5 YEARS POST-IMPLANT WERE REVIEWED. FILMS WERE NON-CONTRAST. THE FILMS REVEALED THAT THE ENDURANT CUFF WAS POSITIONED JUST BELOW THE RENALS. THE PROXIMAL STENT GRAFT OD IS 27MM; THE CUFF IS ANGULATED 65DEG A-P RELATIVE TO THE LIMBS. THE PROXIMAL NECK IS SEVERELY CALCIFIED CIRCUMFERENTIALLY. THE TALENT BIFURCATE WAS POSITIONED APPROXIMATELY 2CM BELOW THE CUFF, AND AN UNKNOWN ANEURX CUFF WAS ALSO SEEN IMPLANTED ACROSS THE FLOW DIVIDER INTO THE LEFT LIMB AND APPEARS CLOSED OFF BY THE ENDURANT AORTIC CUFF. THE BIFURCATE IPSI LIMB WAS PLACED DOWN INTO THE RIGHT COMMON ILIAC ARTERY, AND THE CONTRA LIMB INTO THE LEFT COMMON ILIAC ARTERY. THERE IS MINIMAL SEALING LENGTH DISTALLY; BILATERALLY. LACK OF CONTRAST DOES NOT PERMIT ASSESSMENT OF ANY ENDOLEAK OR STENT GRAFT PATENCY. THE MAX DIAMETER AAA IS 10CM, AND THE AAA APPEARS TO HAVE RUPTURED. FROM THE (NON-CONTRAST) FILMS PROVIDED THE CAUSE OF THE ANEURYSM RUPTURE COULD NOT BE DETERMINED. EARLIER FILMS POST-IMPLANT WERE NOT AVAILABLE FOR REVIEW. THE SOURCE AND CAUSE OF THE POSSIBLE ENDOLEAK COULD NOT BE DETERMINED. IT IS POSSIBLE THAT CONTINUED DISEASE PROGRESSION (NECK DILATATION AND ANGULATION), THE CALCIFIED PROXIMAL NECK, AND THE MINIMAL DISTAL LIMB SEAL LENGTH MAY HAVE ALL CONTRIBUTED.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8.5 CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS REVERSE FUNNEL SHAPED AND VARIED IN DIAMETER FROM 22 MM AT THE RENALS DOWN TO 17 MM AT 15 MM BELOW THE RENALS. THE AORTIC NECK HAD MINIMAL ANGULATION, LITTLE THROMBUS, AND MILD CALCIFICATION. THE PATIENT PRESENTED EMERGENTLY WITH THE 8.5 CM ANEURYSM WITH PAIN BUT WITHOUT A RUPTURE. IT WAS REPORTED A RECENT CT REVEALED THAT THE ILIAC LIMB HAS MIGRATED PROXIMAL DUE TO DISEASE PROGRESSION. THE PHYSICIAN WILL MONITOR THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441389 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00252123

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Death| R