BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 6393881 · Received March 9, 2017

    Report

    Report Number
    2953200-2017-00367
    Event Type
    Death
    Date Received
    March 9, 2017
    Date of Event
    June 5, 2016
    Report Date
    February 15, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: EARLY AND MIDTERM OUTCOMES AFTER TRANSCATHETER EMBOLIZATION OF TYPE I ENDOLEAKS IN 25 PATIENTS. AUTHORS: SEYED AMELI-RENANI, MBBS, FRCR, VYZANTIOS PAVLIDIS, MD, AND ROBERT A. MORGAN (J VASC SURG 2017;65:346-55.) HTTP://DX.DOI.ORG/10.1016/J.JVS.2016.06.101. AN ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE FOLLOWING INFORMATION IS IN THIS JOURNAL ARTICLE: PATIENT 7 WAS TREATED WITH ENDURANT STENT GRAFTS. POST IMPLANTED THE ANEURYSM WAS 70 MM IN DIAMETER. THE PHYSICIAN ELECTED TO TREAT THE PROXIMAL TYPE I LEAK WITH ONYX EMBOLIZATION AGENT. 108 DAYS POST EMBOLIZATION INTERVENTION, THE ANEURYSM SAC HAS INCREASED TO DIAMETER WAS 108 MM. THERE WAS NO INTERVENTION PER THE ARTICLE INFORMATION THE PATIENT WAS UNSUITABLE FOR FURTHER INTERVENTION DUE TO ENDOLEAK MORPHOLOGY AND MULTIPLE COMORBIDITIES INCLUDING CANCER AND CIRRHOSIS. THE PATIENT DIED OF ANEURYSM SAC RUPTURE 121 DAYS AFTER EMBOLIZATION. ABSTRACT OBJECTIVE THIS STUDY REPORTS THE TECHNICAL SUCCESS AND FOLLOW-UP RESULTS OF TRANSCATHETER EMBOLIZATION OF TYPE I ENDOLEAK (ELI) IN 25 PATIENTS AFTER ENDOVASCULAR AORTIC REPAIR (EVAR). METHODS TWENTY-FIVE PATIENTS WITH ELI (20 MEN, FIVE WOMEN; MEAN AGE 80 YEARS; RANGE, 64-96 YEARS) UNDERWENT EMBOLIZATION OF ABDOMINAL ELI (23 PROXIMAL, 2 DISTAL ENDOLEAKS) AFTER EVAR. ALL PATIENTS WERE UNSUITABLE FOR STANDARD ENDOVASCULAR METHODS FOR TREATMENT OF ELI. THE AVERAGE ANEURYSM SAC SIZE BEFORE EMBOLIZATION WAS 8.2 CM (RANGE, 5.3-12.9 CM). THE AVERAGE TIME BETWEEN EVAR AND ENDOLEAK DIAGNOSIS WAS 685 DAYS (RANGE, 1-4220 DAYS) AND FROM ENDOLEAK DIAGNOSIS TO EMBOLIZATION WAS 27 DAYS (RANGE, 2-94 DAYS). ONYX (EV3 ENDOVASCULAR, INC, PLYMOUTH, MINN) ALONE OR WITH DETACHABLE COILS WAS USED FOR EMBOLIZATION. RESULTS A TOTAL OF 27 EMBOLIZATION PROCEDURES WERE PERFORMED, WITH TWO PATIENTS HAVING UNDERGONE A REPEAT PROCEDURE. ONYX ALONE WAS USED IN 16 CASES AND ONYX AND COILS WERE USED IN 11. IMMEDIATE TECHNICAL SUCCESS WITH COMPLETE ISOLATION OF THE ENDOLEAK ON COMPLETION ANGIOGRAPHY WAS ACHIEVED IN ALL PROCEDURES. SIX PROCEDURAL COMPLICATIONS OCCURRED: THREE PUNCTURE SITE HEMATOMAS AND THREE CASES OF NON-TARGET ONYX EMBOLIZATION. NONE OF THE COMPLICATIONS HAD LONG TERM SEQUELAE. DURING THE FOLLOW-UP PERIOD (AVERAGE, 311 DAYS; RANGE, 1-1357 DAYS), SEVEN PATIENTS (28%) DEVELOPED ENDOLEAK RECURRENCE, AND TWO UNDERWENT A SECOND EMBOLIZATION PROCEDURE. OF THESE, ONE HAS HAD NO FURTHER ENDOLEAK RECURRENCE, BUT THE OTHER DEVELOPED A RECURRENT ENDOLEAK AND DIED OF SAC RUPTURE. TWO OF THE OTHER FIVE CASES OF ENDOLEAK RECURRENCE WERE SUCCESSFULLY MANAGED BY OTHER PROCEDURES, ONE HAD A PERSISTENT ENDOLEAK DESPITE AORTIC CUFF PLACEMENT, AND THE OTHER TWO WERE DEEMED UNSUITABLE FOR FURTHER INTERVENTION. THREE OF THE FOUR PATIENTS WITH PERSISTENT ENDOLEAKS DIED OF SAC RUPTURE. AT THE AVERAGE FOLLOW-UP TIME OF 311 DAYS, FREEDOM FROM ENDOLEAK RECURRENCE WAS 80%, AND FREEDOM FROM SAC GROWTH WAS 85%. CONCLUSIONS TRANSCATHETER EMBOLIZATION OF ELI OFFERS A SAFE, FEASIBLE, AND SUSTAINABLE TREATMENT OPTION FOR PATIENTS WHO ARE UNSUITABLE FOR STANDARD METHODS OF ELI TREATMENT. ADDITIONAL COIL EMBOLIZATION BEFORE ONYX INJECTION MAY RESULT IN BETTER OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175070 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| R