BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT XCELERANT HYDRO - BIFUR (OUS)

    MDR report key: 8263787 · Received January 21, 2019

    Report

    Report Number
    2953200-2019-00131
    Event Type
    Injury
    Date Received
    January 21, 2019
    Date of Event
    December 28, 2016
    Report Date
    March 4, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FILM EVALUATION SUMMARY: THE CAUSE OF THE CONTINUED AAA EXPANSION AND EARLIER REPORTED BIFURCATE TYPE IIIB ENDOLEAK COULD NOT BE DETERMINED FROM THE RECENT FILMS PROVIDED. FILMS FROM 2017, JUST PRIOR TO IMPLANTING NON-MDT LIMBS FOR TREATMENT OF THE REPORTED TYPE IIIB ENDOLEAK, WERE NOT PROVIDED. CT¿S RETURNED FROM 7-1/2 YEARS POST-IMPLANT WERE NON-CONTRAST; THEREFORE, THE VESSEL MEASUREMENTS WERE APPROXIMATE, AND NO ASSESSMENT OF ANY ENDOLEAK, VESSEL PATENCY OR THROMBUS COULD BE PERFORMED. THE MAXIMUM AAA DIAMETER MEASURED 104MM. SINCE THE PREVIOUS RETURNED FILMS FROM DEC ¿16, THE AORTIC BODY AND LIMBS HAD BEEN COMPLETELY RELINED WITH NON-MDT STENT GRAFTS LIMBS, FROM THE RENALS TO THE DISTAL COMMON ILIACS. NO STENT GRAFT ISSUES WERE OBSERVED FROM THESE NON-CONTRAST FILMS. REVIEW OF CT¿S FROM 3-MONTHS LATER REVEALED THAT THE MAXIMUM AAA DIAMETER HAD INCREASED TO 106MM; HOWEVER, NO CLEAR ENDOLEAK WAS OBS ERVED. IRREGULAR-SHAPED THROMBUS WAS SEEN WITHIN THE VISCERAL VESSELS, BUT NO OBVIOUS THROMBUS WAS SEEN WITHIN THE STENT GRAFT AORTIC BODY OR LIMBS. NO STENT GRAFT ISSUES WERE OBSERVED. ANALYSIS OF THE RETURNED FILMS DID NOT REVEAL ANY STENT GRAFT OR ANATOMICAL CHARACTERISTICS THAT COULD EXPLAIN THE OBSERVED AAA EXPANSION AND THE PREVIOUSLY REPORTED TYPE IIIB FABRIC ENDOLEAK. IT IS POSSIBLE THAT THE CONTINUED AAA EXPANSION MAY BE DUE TO ENDOTENSION. THE CAUSE OF THE THROMBUS OBSERVED WITHIN THE VISCERAL VESSELS COULD NOT BE DETERMINED. IT IS UNCLEAR IF THIS VESSEL THROMBUS WAS RELATED TO THE THROMBUS OBSERVED WITHIN THE BIFURCATE FROM THE DEC ¿16 FILMS. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    FILM EVALUATION SUMMARY: REVIEW OF CT¿S 2 YEARS POST-IMPLANT ((B)(6) 2013) REVELED THAT A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT. THE BIFURCATE WAS POSITIONED JUST BELOW THE LOWEST LEFT RENAL ARTERY. THE BIFURCATE PROXIMAL OD MEASURED ~21MM, AND ~3CM LOWER MEASURED 22MM IN DIAMETER. A SMALL AMOUNT OF THROMBUS WAS SEEN WITHIN THE AORTIC BODY. THE BIFUR IPSI LIMB, WHICH OPENED ON THE POSTERIOR SIDE OF THE AAA, WAS SLIGHTLY COMPRESSED DOWN TO ~7MM ID NEAR THE FLOW DIVIDER. THE IPSI LIMB OPENED TO 12MM ID WITHIN THE AAA SAC, AND WAS POSITIONED DISTALLY INTO THE LEFT COMMON ILIAC ARTERY. THE CONTRA LIMB WAS PLACED PROXIMALLY AT THE LEVEL OF THE FLOW DIVIDER, AND WAS POSITIONED DISTALLY INTO THE DISTAL PORTION OF THE RIGHT COMMON ILIAC ARTERY. BOTH LIMBS WERE PATENT AND FREE OF THROMBUS. OTHER THAN THE SLIGHT IPSI LIMB COMPRESSION JUST BELOW THE FLOW DIVIDER, THE STENT GRAFT WAS ESSENTIALLY STRAIGHT. THE MAX DIAMET ER AAA MEASURED ~63MM, AND CONTRAST WAS SEEN ALONG THE RIGHT WALL OF THE DISTAL SAC, PRIMARILY OUTSIDE THE RIGHT CONTRA LIMB. THE EXACT ENDOLEAK TYPE AND CAUSE COULD NOT BE DETERMINED. THIS MAY HAVE BEEN A TYPE II FROM A NEARBY LUMBAR ARTERY. A POSSIBLE TYPE III FABRIC FROM THE CONTRA LIMB CANNOT BE RULED OUT; CALCIFICATION WAS SEEN NEAR THE LOCATION OF THE ENDOLEAK. NO OTHER STENT GRAFT ISSUES WERE OBSERVED. REVIEW OF CT¿S FROM 5- ½ YEARS POST-IMPLANT ((B)(6) 2016) REVEALED THAT THE BIFURCATE WAS POSITIONED JUST BELOW THE LEFT RENAL ARTERY. THE BIFURCATE PROXIMAL OD MEASURED ~22MM AND THROMBUS WAS SEEN WITHIN THE AORTIC BODY (INCREASED AMOUNT COMPARED TO 2 YEAR STUDY). THE MAXIMUM DIAMETER AAA HAS INCREASED TO 87MM, HOWEVER NO CONTRAST WAS SEEN WITHIN THE AAA SAC. SINCE THE PREVIOUS STUDY COILS HAD BEEN PLACED ALONG THE POSTERIOR AAA AS WELL AS WITHIN THE RIGHT WALL OF THE AAA, NEAR TO THE PREVIOUSLY SEEN CONTRAST. BOTH LIMBS WERE PATENT AND WELL POSITIONED INTO THE ILIAC ARTERIES. NO OTHER ISSUES WERE OBSERVED. THE CAUSE OF THE AAA EXPANSION COULD NOT BE DETERMINED FROM THE FILMS PROVIDED. THE PRE-IMPLANT FILMS REVEALED THAT THE NECK WAS FILLED WITH THROMBUS AND WAS EXTENSIVELY CALCIFIED, MULTIPLE PAIRS OF LUMBAR ARTERIES WERE SEEN FEEDING THE SAC, AND THE ILIAC ARTERIES WERE DISEASED BILATERALLY. FILMS 2 YEARS POST-IMPLANT CONFIRMED INCREASING AAA SIZE WITH CONTRAST ALONG THE RIGHT WALL OF THE DISTAL SAC, PRIMARILY OUTSIDE THE RIGHT CONTRA LIMB. THE EXACT ENDOLEAK TYPE AND CAUSE COULD NOT BE DETERMINED. THIS MAY HAVE BEEN FROM A TYPE II FROM A NEARBY LUMBAR ARTERY, OR POSSIBLY A TYPE III FABRIC ENDOLEAK FROM THE CONTRA LIMB, WITH CALCIFICATION SEEN NEAR THE LOCATION OF THE ENDOLEAK. FILMS FROM 5 ½ YEARS POST IMPLANT COULD NOT CONFIRM ANY ENDOLEAK. THE MAXIMUM DIAMETER AAA HAS INCREASED TO 87MM, HOWEVER NO CONTRAST WAS SEEN WITHIN THE AAA SAC. SINCE THE PREVIOUS STUDY, COILS HAD BEEN PLACED ALONG THE POSTERIOR AAA AS WELL AS WITHIN THE RIGHT WALL OF THE AAA, NEAR TO THE PREVIOUSLY SEEN CONTRAST AT 2 YEARS. IT THEREFORE SEEMS POSSIBLE THAT THE INITIALLY SEEN AAA EXPANSION WAS FROM A TYPE II LUMBAR WHICH WAS CORRECTED BY COILING, HOWEVER THE CURRENT INCREASE IN AAA DIAMETER COULD NOT BE EXPLAINED FROM THE CT¿S PROVIDED. ADDITIONAL ANGIOGRAPHIC ASSESSMENT MAY HELP IDENTIFY THE SOURCE OF THE EXPANSION. THROMBUS WAS SEEN WITHIN THE AORTIC BODY ON BOTH POST-IMPLANT CT¿S; HOWEVER, THE CAUSE COULD NOT BE DETERMINED. 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 A 54 MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE ANEURYSM ENLARGEMENT WAS OBSERVED DURING A FOLLOW UP VISIT AFTER IMPLANT. APPROXIMATELY TWO YEARS AFTER IMPLANT A TYPE II WAS SUSPECTED AND COILING WAS PERFORMED; HOWEVER, THE ANEURYSM ENLARGEMENT CONTINUED. APPROXIMATELY FIVE YEARS AFTER IMPLANT THE ANEURYSM ENLARGEMENT WAS STILL CONTINUING, BUT NO ENDOLEAK COULD BE CONFIRMED. IT WAS NOTED THAT THE PROXIMAL NECK HAD SHORTENED SLIGHTLY DUE TO THE ENLARGEMENT IN THE ANEURYSM DIAMETER. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT WAS REPORTED THAT INTERVENTION WAS CARRIED OUT APPROXIMATELY SIX YEARS AFTER THE INDEX PROCEDURE TO TREAT A TYPE IIIB ENDOLEAK IN THE BIFURCATED STENT GRAFT USING NON-MDT CUFFS AND LIMBS TO RELINE THE PREVIOUSLY IMPLANTED STENT GRAFT AND AT THIS TIME IT WAS NOTED THAT THE ANEURYSM WAS 82*88MM IN DIAMETER. A FOLLOW UP VISIT APPROXIMATELY A YEAR AND A HALF POST THE INTERVENTION PROCEDURE SHOWED THE ANEURYSM HAD INCREASED TO 92*105MM IN DIAMETER. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56519 TALENT XCELERANT HYDRO - BIFUR (OUS) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND AF2414C140XHJ

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention