BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC ANEURX STENT GRAFT SYSTEM

    MDR report key: 1560512 · Received December 14, 2009

    Report

    Report Number
    2953200-2009-01795
    Event Type
    Death
    Date Received
    December 14, 2009
    Date of Event
    May 14, 2009
    Report Date
    November 14, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: (IDENTITY OF DEVICE AND OTHER DETAILS WERE NOT PROVIDED). (DEATH, RUPTURE, ENDOLEAK). CONCLUSION: THE PHYSICIAN WAS CONTACTED FOR SPECIFIC INFO REGARDING THE EVENTS INCLUDING THE CATALOG AND LOT NUMBERS FOR THE TALENT AND ANEURX DEVICES. AT THIS TIME, THE INFO WAS NOT PROVIDED. (J VASC SURG 2009; 50:714-21).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: OPEN SURGICAL REPAIR AFTER FAILED ENDOVASCULAR ANEURYSM REPAIR: IS ENDOGRAFT REMOVAL NECESSARY' (J VASC SURG 2009; 50:714-21). OPEN SURGICAL REPAIR AFTER FAILED ENDOVASCULAR ANEURYSM REPAIR: IS ENDOGRAFT REMOVAL NECESSARY' (J VASC SURG 2009; 50:714-21). DIVISION OF VASCULAR AND ENDOVASCULAR SURGERY, A MEDICAL CENTER. RECENT REPORTS HAVE SUGGESTED THAT TOTAL ENDOGRAFT REMOVAL DURING LATE SURGICAL CONVERSION MAY NOT BE NECESSARY AND THAT PRESERVING FUNCTIONAL PARTS OF THE ENDOGRAFT MAY IMPROVE RESULTS. WE HAVE APPROACHED THE ISSUE OF LATE SURGICAL CONVERSION WITH THE OBJECTIVE OF LIMITING THE MAGNITUDE OF THE PROCEDURE AND PRESERVING THE FUNCTIONING ENDOGRAFT, WHEN POSSIBLE. WE REPORT OUR EXPERIENCE WITH LATE SURGICAL CONVERSION AFTER FAILED EVAR USING THIS APPROACH. A RETROSPECTIVE REVIEW OF ALL PTS REQUIRING DELAYED CONVERSION TO OPEN REPAIR AT THE MEDICAL CENTER AFTER FAILED EVAR FROM 2000 TO 2008 WAS PERFORMED. DELAYED SURGICAL CONVERSION WAS DEFINED AS ANY OPEN ABDOMINAL SURGICAL PROCEDURE TO REPAIR THE ANEURYSM >30 DAYS AFTER INITIAL ENDOGRAFT IMPLANTATION. DURING THIS TIME, 12 PTS WERE TREATED WITH DELAYED OPEN SURGICAL CONVERSION, INCLUDING EIGHT PTS INITIALLY TREATED AT OUR OWN INSTITUTION AND FOUR INITIALLY TREATED ELSEWHERE WITH SUBSEQUENT REFERRAL FOR THE TREATMENT OF PERSISTENT PROXIMAL TYPE I ENDOLEAKS WITH ANEURYSM ENLARGEMENT AFTER EVAR. SEE MFR # 2953200-2009-01796. PRIMARY EVAR PROCEDURES WERE PERFORMED WITH A VARIETY OF ENDOGRAFTS, INCLUDING SIX INFRARENAL (50%) AND SIX SUPRARENAL (50%) DEVICES. ONE INFRARENAL DEVICE WITH HOOKS AT THE PROXIMAL ATTACHMENT SITE WAS PLACED; ALL OTHER ENDOGRAFTS LACKED HOOKS OR BARBS. AVERAGE TIME TO CONVERSION WAS 44.7 MONTHS (RANGE, 7-80 MONTHS). COMPLETE ENDOGRAFT PRESERVATION WAS ATTEMPTED IN EIGHT PTS AND WAS SUCCESSFUL IN SIX (75%). THE TWO PTS THAT FAILED THIS APPROACH, AS WELL AS FOUR ADDITIONAL PTS WHO WERE NOT CANDIDATES FOR THIS APPROACH, UNDERWENT PARTIAL ENDOGRAFT EXCISION AND REPLACEMENT WITH AN INTERPOSITION GRAFT SUTURED TO THE REMAINING PORTION OF THE STENT GRAFT. COMPLETE ENDOGRAFT REMOVAL WAS NOT REQUIRED IN ANY PTS. THERE WAS ONE POST-OPERATIVE MORTALITY (8.3%) AND ONE SIGNIFICANT POST-OPERATIVE MORBIDITY (8.3%). SURGICAL APPROACH: THE SURGICAL APPROACH FOR PTS REQUIRING CONVERSION WAS INDIVIDUALIZED AND FOCUSED ON SECURING PROXIMAL FIXATION AND SEAL OF THE ENDOGRAFT WITH PRESERVATION OF THE ENDOGRAFT, IF POSSIBLE. THIS WAS APPROACHED IN ONE OF TWO WAYS: COMPLETE ENDOGRAFT PRESERVATION WITH EXTERNAL WRAP OF THE AORTIC NECK TO SECURE A PROXIMAL SEAL AND ELIMINATE TYPE I ENDOLEAK, OR PARTIAL ENDOGRAFT REMOVAL WITH INTERPOSITION OF A SURGICAL PROSTHETIC GRAFT FROM THE INFRARENAL AORTIC NECK TO THE REMAINING ENDOGRAFT OR ILIAC LIMBS. COMPLETE ENDOGRAFT PRESERVATION: SELECTION FOR THE PROCEDURE REQUIRED A SATISFACTORY AORTIC NECK LENGTH, GOOD JUXTARENAL ENDOGRAFT POSITION, AND A TYPE I ENDOLEAK AS A RESULT OF POOR PROXIMAL SEAL OF THE ENDOGRAFT (WHETHER DUE TO NECK ENLARGEMENT OR SEVERE NECK ANGULATION). THE PT UNDERWENT CONVERSION WITH CREATION OF A PROXIMAL AORTIC WRAP ALLOWING COMPLETE ENDOGRAFT PRESERVATION. PARTIAL ENDOGRAFT PRESERVATION. PTS WITH INTACT DISTAL FIXATION BUT WITH FAILED PROXIMAL FIXATION, WHO WERE NOT CANDIDATES FOR COMPLETE ENDOGRAFT PRESERVATION, WERE CANDIDATES FOR PARTIAL ENDOGRAFT PRESERVATION. A PT WAS NOT A CANDIDATE FOR COMPLETE ENDOGRAFT PRESERVATION WHEN PREOPERATIVE IMAGING DEMONSTRATED A SHORT, ANGULATED AORTIC NECK WITH LOW POSITION OF THE ENDOGRAFT IN THE NECK AND ENDOGRAFT MIGRATION OR SEVERE ANGULATION OF THE ENDOGRAFT WITHIN THE ANEURYSM SAC. CONCLUSIONS: OPEN SURGICAL REPAIR OF FAILED EVAR CAN BE ACCOMPLISHED WITH PRESERVATION OF ALL OR A SIGNIFICANT PORTION OF THE ENDOGRAFT IN MOST PTS. THIS MAY LIMIT THE MAGNITUDE OF THE REPAIR PROCEDURE AND MAY REDUCE MORBIDITY AND MORTALITY. IT IS UNK WHICH DEVICE LED TO WHICH PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death