BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM

    MDR report key: 2863354 · Received December 10, 2012

    Report

    Report Number
    2953200-2012-02367
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). (UNKNOWN CAUSE OF EVENT). CONCLUSION: (UNKNOWN CAUSE OF EVENT).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: THE USE OF ENDOANCHORS IN REPAIR EVAR CASES TO IMPROVE PROXIMAL ENDOGRAFT FIXATION, JOURNAL OF CARDIOVASCULAR SURGERY VOL.53 (4) P419-26 AUG 2012. AIM. THE AIM OF THIS PAPER WAS TO EVALUATE SHORT-TERM OUTCOME OF THE USE OF ENDOANCHORS TO SECURE THE PRIMARY MIGRATED ENDOGRAFT AND ADDITIONAL EXTENDER CUFFS TO THE AORTIC WALL IN PATIENTS WITH PREVIOUS FAILED ENDOVASCULAR AORTIC ANEURYSM REPAIR. METHODS. CONSECUTIVE PATIENTS WHO NEEDED PROXIMAL REPAIR OF A PRIMARY FAILED ENDOGRAFT DUE TO MIGRATION (WITH OR WITHOUT TYPE IA ENDOLEAKS) WERE TREATED WITH ENDOANCHORS, WITH OR WITHOUT ADDITIONAL EXTENDER CUFFS. DATA OF THIS GROUP WERE PROSPECTIVELY GATHERED IN VASCULAR REFERRAL CENTERS THAT WERE EARLY ADOPTERS OF THE ENDOANCHOR TECHNIQUE. PREPROCEDURAL AND PERIPROCEDURAL DATA WERE PROSPECTIVELY GATHERED AND RETROSPECTIVELY ANALYZED. FOLLOW-UP AFTER ENDOANCHOR PLACEMENT CONSISTED OF REGULAR HOSPITAL VISITS, WITH COMPUTED TOMOGRAPHY OR DUPLEX SCANNING AT 1,6, AND 12 MONTHS. RESULTS. FROM (B)(6) 2010 TO (B)(6) 2011, 11 PATIENTS (8 MEN), MEAN AGE 77 YEARS (RANGE, 59-88 YEARS), WERE TREATED WITH ENDOANCHORS FOR A FAILED PRIMARY ENDOGRAFT (2 EXCLUDER ENDOGRAFTS, 1 ANEURX ENDOGRAFT, AND 8 TALENT ENDOGRAFTS) DUE TO DISTAL MIGRATION OF THE MAIN BODY, WITH OR WITHOUT TYPE IA ENDOLEAK. REVISION CONSISTED OF USING ENDOANCHORS TO SECURE THE BODY OF THE PRIMARY ENDOGRAFT TO THE AORTIC WALL TO AVOID PERSISTENT MIGRATION. MOST PATIENTS HAD ADDITIONAL PROXIMAL EXTENDER CUFFS WITH SUPRARENAL FIXATION, WHICH WERE SECURED WITH ENDOANCHORS TO THE AORTIC WALL AND IN SOME PATIENTS ALSO TO THE PRIMARY ENDOGRAFT. A MEDIAN OF 6 ENDOANCHORS WERE IMPLANTED. ALL ENDOANCHORS WERE POSITIONED CORRECTLY BUT ONE. ONE ENDOANCHOR DISLODGED BUT WAS SUCCESSFULLY RETRIEVED USING AN ENDOVASCULAR SNARE. DURING A MEAN FOLLOW-UP OF 10 MONTHS (RANGE, 3-18 MONTHS) NO ENDOANCHOR-RELATED COMPLICATIONS OR RENEWED MIGRATION OF THE ENDOGRAFTS OCCURRED. TWO PATIENTS UNDERWENT REPEAT INTERVENTION DUE TO A PERSISTENT TYPE IA ENDOLEAK DURING FOLLOW-UP. CONCLUSION. THE USE OF ENDOANCHORS TO SECURE MIGRATED ENDOGRAFTS TO THE AORTIC WALL IS SAFE AND FEASIBLE AND MIGHT HELP TO OVERCOME PERSISTENT MIGRATION OF PRIMARY FAILED ENDOGRAFTS. IN COMBINATION WITH THE USE OF SOLE EXTENDER CUFFS THE MAJORITY OF PROXIMAL EVAR FAILURES CAN BE SOLVED. PATIENT (B)(6): THE PATIENT HAD UNDERGONE PRIMARY ELECTIVE REPAIR OF AN INFRARENAL ABDOMINAL AORTIC ANEURYSM WITH BIFURCATED ENDOGRAFTS. IT WAS REPORTED THAT THIS PATIENT WAS TREATED FOR A PROXIMAL TYPE I ENDOLEAK WITHOUT DISTAL MIGRATION OF THE PRIMARY ENDOGRAFT. THE PATIENT UNDERWENT UNEVENTFUL ENDOANCHOR IMPLANTATION AND PLACEMENT OF AN ADDITIONAL CUFF.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention