BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3143189 · Received May 28, 2013

    Report

    Report Number
    2017233-2013-00341
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    June 1, 2009
    Report Date
    April 30, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANEURYSM GROWTH IN THE ABSENCE OF ENDOLEAK HAS BEEN DEFINED AS ENDOTENSION. ONE HYPOTHESIS FOR THE SOURCE OF ENDOTENSION IS THE TRANSMURAL MOVEMENT OF SEROUS FLUID ACROSS THE MATERIAL USED TO FABRICATE DEVICES USED TO TREAT THE AORTIC ABDOMINAL ANEURYSM. IN RESPONSE TO THIS ISSUE, GORE ELECTED IN 2004 TO PROVIDE A DESIGN ENHANCEMENT TO THE ORIGINAL GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    IN REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED. F FILIPPI, C TIROTTI, N STELLA, L RIZZO AND M TAURINO, "ENDOTENSION-RELATED AORTIC SAC RUPTURE TREATED BY ENDOGRAFT RELINING" VASCULAR, VOL. 21 NO. 2, PP. 113-115, 2013. IN THIS CASE REPORT IS DESCRIBED A CASE OF A PATIENT TREATED WITH A FIRST GENERATION GORE AAA BIFURCATED ENDOPROSTHESIS FOR ABDOMINAL AORTIC ANEURYSM, WITH LATE ANEURYSMAL SAC ENLARGEMENT WITHOUT EVIDENCE OF ENDOLEAK AND SUBSEQUENT CONTAINED RUPTURE WITHOUT ANEMIA AND SHOCK. WE HAVE SUCCESSFULLY TREATED THE PATIENT BY ENDOVASCULAR PROCEDURE, THROUGH BILATERAL PERCUTANEOUS FEMORAL APPROACH, WITH RELINING TECHNIQUE. THREE YEARS CT SCAN FOLLOW-UP SHOWED THE ENDOGRAFT PATENCY AND SIZE SAC REDUCTION. THE ARTICLE DESCRIBES A (B)(6) MAN AFFECTED BY END-STAGE RENAL DISEASE IN DIALYSIS, PREVIOUS MYOCARDIAL INFARCTION AND ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR, PERFORMED IN 2002 WITH FIRST GENERATION GORE AAA BIFURCATED ENDOPROSTHESIS. THE PATIENT WAS ADMITTED IN (B)(6) 2009 WITH SUDDEN ABDOMINAL AND LUMBAR PAIN. A CONTRAST CT SHOWED A 2 CM INCREASED ANEURISMAL SAC SIZE. FIVE DAYS AFTER ADMISSION, CT SCAN SHOWED A SAC DIAMETER GROWTH AND A DISCONTINUITY OF ANTERIOR SIDE WALL OF THE SAC, WITH DISSEMINATION OF HYPODENSE CORPUSCULATED FLUID, WITHOUT SIGNS OF ENDOLEAK. BECAUSE OF THE CLINICAL CONDITIONS, AN ENDOVASCULAR APPROACH WITH RELINING TECHNIQUE WAS CHOSEN. THE PREOPERATIVE ANGIOGRAPHY SHOWED NO ENDOLEAK. BECAUSE OF ILIAC ARTERY AND AORTIC NECK TORTUOSITY, AN ENDURANT (MEDTRONIC VASCULAR, (B)(4) USA) DEVICE WAS INDICATED. THE LATEST CT, AT THREE YEARS AFTER THE PROCEDURE, SHOWED THE ENDOGRAFT PATENCY AND A NET REDUCTION SIZE SAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233352 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R