BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 11479382 · Received March 15, 2021

    Report

    Report Number
    3007284313-2021-01318
    Event Type
    Death
    Date Received
    March 15, 2021
    Date of Event
    May 14, 2020
    Report Date
    July 20, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: TYPE 2 ENDOLEAKS: COMMON AND HARD TO ERADICATE YET BENIGN? LIANG MENG LOY, JASMINE MING ER CHUA, TZE TEC CHONG, ET AL. HTTPS://DOI.ORG/10.1007/S00270-020-02497-3 CARDIOVASC INTERVENT RADIOL (2020) 43:963¿970.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS RECEIVED THROUGH LITERATURE ARTICLE ¿TYPE 2 ENDOLEAKS: COMMON AND HARD TO ERADICATE YET BENIGN?¿ PUBLISHED IN CARDIOVASCULAR INTERVENTIONAL RADIOLOGY ON 14 MAY 2020. THIS WAS A STUDY OF PATIENTS WHO UNDERWENT ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) BETWEEN FEBRUARY 2006 AND DECEMBER 2016. A TOTAL OF 156 PATIENTS UNDERWENT EVAR, OF WHICH 67 DEVELOPED T2ELS (TYPE 2 ENDOLEAKS). OUT OF THE 67 PATIENTS, 7 WERE LOST TO FOLLOW-UP. OUT OF THE REMAINING 60 PATIENTS WITH FOLLOW-UP, 2 (3.3%) WERE TREATED WITH EXCLUDER DEVICE AT THE INITIAL PROCEDURE. THE OTHERS WERE TREATED WITH NON-GORE DEVICES. ONE PATIENT MENTIONED IN THE ¿CONCOMITANT TIEL AND/OR T3EL¿ SECTION. THIS 70 YEARS OLD PATIENT WITH 7.2 CM LEAKING AAA WHO UNDERWENT EVAR WITH AN GORE EXCLUDER AAA ENDOPROSTHESIS. THERE WAS NO ENDOLEAK ON THE COMPLETION ANGIOGRAM. HOWEVER, TYPE 1A ENDOLEAK AND T2EL (ARISING FROM LUMBAR ARTERY) WERE DETECTED ON CTA 1 MONTH POST EVA-, WITH STABLE SAC SIZE. THE TYPE 1A ENDOLEAK WAS TREATED WITH A PROXIMAL AORTIC EXTENSION CUFF. BOTH ENDOLEAKS PERSISTED ON FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) AND CONTRAST-ENHANCED ULTRASOUND (CEUS), ALBEIT WITH STABLE SAC SIZE. THIS WAS EVENTUALLY COMPLICATED BY SAC RUPTURE 3 YEARS LATER. HE WAS NOT FIT FOR SURGERY OR FURTHER REINTERVENTION AND PASSED AWAY.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED THROUGH LITERATURE ARTICLE ¿TYPE 2 ENDOLEAKS: COMMON AND HARD TO ERADICATE YET BENIGN?¿ PUBLISHED IN CARDIOVASCULAR INTERVENTIONAL RADIOLOGY (2020) 43:963¿970 ON 14 MAY 2020. THE AUTHORS: LIANG MENG LOY, JASMINE MING ER CHUA, TZE TEC CHONG, ET AL. THIS WAS A STUDY OF PATIENTS WHO UNDERWENT ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) BETWEEN FEBRUARY 2006 AND DECEMBER 2016. A TOTAL OF 156 PATIENTS UNDERWENT EVAR, OF WHICH 67 DEVELOPED TYPE II ENDOLEAKS. OUT OF THE REMAINING 60 PATIENTS WITH FOLLOW-UP, 2 (3.3%) WERE TREATED WITH EXCLUDER DEVICE AT THE INITIAL PROCEDURE. 45 (75.0%) WERE TREATED WITH ZENITH DEVICE, 7 (11.7%) WERE TREATED WITH ENDURANT DEVICE, 6 (10.0%) WERE TREATED WITH OTHERS DEVICE. 41 PATIENTS HAD ISOLATED TYPE II ENDOLEAK, 19 HAD CONCOMITANT TYPE I ENDOLEAK AND/OR TYPE III ENDOLEAK. AMONGST THOSE WITH PERSISTENT TYPE II ENDOLEAKS ASSOCIATED WITH SAC GROWTH (N = 17), 14 UNDERWENT INTERVENTION, OF WHICH 7 RECEIVED >1 EMBOLIZATION PROCEDURE. ONE PATIENT MENTIONED IN THE ¿CONCOMITANT TIEL AND/OR T3EL¿ SECTION. THIS 70 YEARS OLD PATIENT WITH 7.2 CM LEAKING AAA WHO UNDERWENT EVAR WITH AN GORE EXCLUDER DEVICE. THERE WAS NO ENDOLEAK ON THE COMPLETION ANGIOGRAM. HOWEVER, TYPE IA ENDOLEAK AND TYPE II ENDOLEAK (ARISING FROM LUMBAR ARTERY) WERE DETECTED ON CTA 1 MONTH POST EVAR, WITH STABLE SAC SIZE. THE TYPE IA ENDOLEAK WAS TREATED WITH A PROXIMAL AORTIC EXTENSION CUFF. BOTH ENDOLEAKS PERSISTED ON FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) AND CONTRAST-ENHANCED ULTRASOUND (CEUS), ALBEIT WITH STABLE SAC SIZE. THIS WAS EVENTUALLY COMPLICATED BY SAC RUPTURE 3 YEARS LATER. THE PATIENT WAS NOT FIT FOR SURGERY OR FURTHER REINTERVENTION AND PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377626 GORE EXCLUDER AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death