BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT BIFUR XCELERANT

    MDR report key: 6883908 · Received September 21, 2017

    Report

    Report Number
    2953200-2017-01467
    Event Type
    Injury
    Date Received
    September 21, 2017
    Date of Event
    October 1, 2016
    Report Date
    November 8, 2017
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FILM SUMMARY REVIEW: REVIEW OF FOUR (4) STILL ANGIOGRAMS DURING AN INTERVENTION (UNKNOWN STUDY DATE) CONFIRMED THAT THE TALENT AAA STENT GRAFT SYSTEM HAD BEEN IMPLANTED IN THE PATIENT. PER THE CALIBRATED CATHETER, THE BIFURCATE HAD FALLEN INTO THE SAC AND WAS POSITIONED ~5CM BELOW THE RENAL ARTERIES. THE APPROXIMATE NECK DIAMETER JUST BELOW THE RENAL ARTERIES MEASURED 24MM, AND THE REMAINING NECK LENGTH WAS <(><<)>(><(><<)><(> <<)>)>5MM. TEN (10MM) BELOW THE RENALS THE AORTIC DIAMETER WAS 36MM, AND NEAR THE LEVEL OF THE BIFURCATE PROXIMAL MARGIN MEASURED 60MM. THE BIFURCATE WAS ACUTELY ANGULATED AT THE FLOW DIVIDER ~60 DEG RELATIVE TO THE ILIAC LIMBS, WHERE IT WAS POTENTIALLY KINKED, AND BOTH LIMBS COURSED DISTALLY INTO THE ILIAC ARTERIES WITH LITTLE LIMB COMPRESSION OR OBVIOUS KINKS OBSERVED. THE REMAINING IMAGES REVEALED THAT A FENESTRATED COOK DEVICE WAS IMPLANTED INTO THE BIFURCATE, POSITIONED PROXIMALLY TO JUST BELOW THE LEVEL OF THE SMA, WITH BILATERAL STENTS PROVIDING BLOOD FLOW TO BOTH RENAL ARTERIES. NO ENDOLEAK WAS SEEN FROM THE FINAL ANGIOGRAM IMAGE. THE EXACT CAUSE OF THE TALENT MIGRATION LEADING TO THE PROXIMAL TYPE I ENDOLEAK COULD NOT BE DETERMINED FROM THE LIMITED FILMS PROVIDED. THE ANATOMY AT IMPLANT AND EARLIER POST-IMPLANT FILMS WERE NOT AVAILABLE FOR REVIEW. FOUR (4) STILL ANGIOGRAMS DURING A RECENT INTERVENTION CONFIRMED THE BIFURCATE HAD FALLEN INTO THE SAC AND WAS POSITIONED ~50MM BELOW THE RENAL ARTERIES. THE APPROXIMATE NECK DIAMETER JUST BELOW THE RENAL ARTERIES MEASURED 24MM, AND THE REMAINING NECK LENGTH WAS <(> <<)>(> <(><<)><(><<)>)>5MM. TEN (10MM) BELOW THE RENALS THE AORTIC DIAMETER WAS 36MM, AND NEAR THE LEVEL OF THE BIFURCATE PROXIMAL MARGIN MEASURED 60MM IN DIAMETER. IT APPEARS LIKELY THAT THERE HAS BEEN DISEASE PROGRESSION (NECK DILATATION) LEADING TO THE LACK OF STENT GRAFT RADIAL APPOSITION WITH STENT GRAFT MIGRATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THERE WAS AN UNKNOWN DEVICE ISSUE. THE PHYSICIAN ELECTED TO PERFORM AN INTERVENTION. AN INITIAL AORTOGRAM DEMONSTRATED THAT THE TALENT STENT GRAFT BIFURCATE WAS POSITIONED 5 CM TO CM DISTAL TO THE RENAL ARTERIES AND PARTIAL CONTRAST FILLING OF A JUXTA-RENAL ABDOMINAL AORTIC ANEURYSM WAS OBSERVED. ANOTHER MANUFACTURER'S [DRYSEAL] 18 FR SHEATH WAS PLACED IN THE PATIENT'S RIGHT ILIAC ARTERY/ ANOTHER MANUFACTURER'S [COOK] FENESTRATED AORTIC CUFF WAS IMPLANTED FROM THE PATIENT'S LEFT ILIAC ARTERY. THE LEFT AND RIGHT RENAL ARTERIES WERE THEN ACCESSED THROUGH THE FENESTRATED AORTIC CUFF AND TWO OF ANOTHER MANUFACTURER'S [GORE VBX] STENTS WERE IMPLANTED IN THE RENAL ARTERIES. AN ENDURANT LIMB EXTENSION [20X20X82 WAS THEN PLACED ON THE RIGHT AND THE LEFT TO BRIDGE THE DISTAL FNESTRATED AORTIC CUFF WITH THE ILIAC LIMBS OF THE PREVIOUSLY IMPLANTED TALENT BIFURCATE. IN ORDER TO INCREASE DISTAL OVERLAP, AN ADDITIONAL ENDURANT [20X20X82] STENT GRAFT LIMB WAS IMPLANTED ON THE LEFT SIDE AND AN ADDITIONAL ENDURANT [24X24X82] STENT GRAFT LIMB EXTENSION WAS IMPLANTED ON THE RIGHT SIDE. A FINAL ANGIOGRAM DEMONSTRATED EXCLUSION OF THE ABDOMINAL AORTIC ANEURYSM, PATENT VISCERAL VESSELS, AND PATENT ILIAC ARTERIES BILATERALLY. THE CAUSE OF EVENT IS UNKNOWN, AS THIS WAS REPORTED FROM THE PATIENT¿S FAMILY MEMBER. NO ADDITIONAL INFORMATION COULD BE OBTAINED FROM THE PHYSICIAN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THEIR PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664818 TALENT BIFUR XCELERANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA AF3618C155XH

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention