BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA

    MDR report key: 3143538 · Received June 3, 2013

    Report

    Report Number
    2953200-2013-01051
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 17, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS: FILMS.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ANEURYSM ENLARGEMENT); (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN). CONCLUSIONS: KNOWN INHERENT RISK OF A PROCEDURE (ANEURYSM ENLARGEMENT); (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN).

    Description of Event or Problem · 1

    A TALENT TAA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. A 7.2 CM IN DIAMETER SACCULAR ANEURYSM WITH A LENGTH OF 40MM WAS REPORTED. THE PROXIMAL AORTA WAS 29 MM IN DIAMETER AND 80 MM IN LENGTH FROM THE BOTTOM OF THE ARCH TO THE PROXIMAL ANEURYSM. THE DISTAL AORTA WAS 29-24 MM IN DIAMETER AND 40MM LONG. A TALENT 3636114 AND A TALENT 3834112 WERE IMPLANTED IN ZONE 3. THE IMPLANT PROCEDURE WAS UNREMARKABLE WITH NO REPORTED ADVERSE EVENTS OR TECHNICAL OBSERVATIONS. IT WAS REPORTED THAT THE 1 MONTH CT WITH CONTRAST SHOWED THE ANEURYSM TO BE 68MM IN DIAMETER AND 75MM LONG. THE 12 MONTH CT SHOWED THE ANEURYSM TO HAVE INCREASED IN SIZE TO 77MM IN DIAMETER AND 75MM LONG. THE 2 YEAR IMAGING SHOWED THE ANEURYSM TO BE 83MM IN DIAMETER AND 51MM LONG. THE 3 YEAR CT SHOWED THE ANEURYSM TO BE 69MM IN DIAMETER AND 75MM LONG. THE 3 YEAR CT ALSO SHOWED EVIDENCE OF A POSSIBLE COMPONENT SEPARATION. NO ENDOLEAKS, MIGRATIONS, OR OTHER TECHNICAL OBSERVATIONS WERE NOTED THROUGHOUT THE FOLLOW-UP PERIOD. A SECONDARY INTERVENTION WAS PERFORMED APPROXIMATELY 3 YEARS POST-IMPLANT. NO ENDOLEAK WAS VISUALIZED ON THE ANGIOGRAM, BUT THE COMPONENTS WERE VERY CLOSE TO SEPARATING. A 40MM STENT WAS IMPLANTED TO BRIDGE THE GAP. A RIGHT COMMON ILIAC STENT WAS ALSO PLACED TO ADDRESS A MINOR ACCESS ISSUE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    THE PREVIOUSLY REPORTED 40MM STENT WAS CONFIRMED TO BE A VALIANT 40X40X150. THE PHYSICIAN ATTEMPTED TO ADVANCE THIS DEVICE INTO THE PATIENT BUT ENCOUNTERED DIFFICULTY AT THE PROXIMAL COMMON ILIAC ARTERY. AN ANGIOGRAM WAS PERFORMED FOLLOWED BY PASSAGE OF ANOTHER MANUFACTURER¿S HYDROPHILIC DILATOR UP TO 24 FR. THE STENT GRAFT WAS THEN ADVANCED THROUGH THE ILIAC ARTERY AND IMPLANTED. A COMPLETION ANGIOGRAM REVEALED A NON-FLOW LIMITING DISSECTION OF THE RIGHT COMMON ILIAC ARTERY. THIS WAS BALLOON DILATED AND STENTED USING ANOTHER MANUFACTURER¿S BARE METAL STENT. A FOLLOW-UP ANGIOGRAM WAS PERFORMED, DEMONSTRATING NO FURTHER DISSECTION. THE INVESTIGATOR STATED THAT A FOCAL STENOSIS MAY HAVE CONTRIBUTED TO THE POSITIONING DIFFICULTY.

    Description of Event or Problem · 1

    A REVIEW OF CTA'S 3 YEARS POST-IMPLANT SHOWED THAT THE DEVICES WERE IMPLANTED FROM THE DESCENDING THORACIC DISTALLY JUST PROXIMAL TO THE CELIAC. NO ENDOLEAK WAS SEEN AT THE JUNCTION OR OTHER LOCATION. THE OVERLAPPING AREA WAS SLIGHTLY ANGULATED L-R. X-RAY IMAGES FROM THE SAME DATE SHOW PARTIAL SEPARATION OF THE DEVICES IN THE ANGULATED OVERLAPPING REGION. EARLIER POST-IMPLANT IMAGES WERE NOT PROVIDED; THE AMOUNT OF INITIAL OVERLAP IS UNKNOWN AND THE CAUSE OF THE SEPARATION IS UNKNOWN. THE OVERLAPPING AREA OCCURRED WITHIN THE TAA WHICH MAY HAVE ALLOWED MORE STENT GRAFT MOVEMENT WITH ANY TAA MORPHOLOGY CHANGES. IT IS POSSIBLE THAT THE 2MM OVERSIZING, LESS THAN RECOMMENDED 4MM COMPONENT DIAMETER OVERSIZING, MAY HAVE CONTRIBUTED. IMAGES POST-IMPLANT OF THE 40MM CUFF USED TO RELINE THE SEPARATION WERE NOT PROVIDED, AND THE REPORTED ILIAC DISSECTION COULD NOT BE ASSESSED AS THE IMAGES REVIEWED WERE ONLY OF THE THORACIC AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243453 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00484932

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention