BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 7060353 · Received November 27, 2017

    Report

    Report Number
    2953161-2017-00221
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    October 28, 2017
    Report Date
    May 17, 2018
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE RETURNED TO W. L. GORE & ASSOCIATES FOR INVESTIGATION. SUBMITTED WHOLE OR IN PART IN FORMALIN WERE FOUR GORE® EXCLUDER® AAA AND ILIAC BRANCH ENDOPROSTHESES; ONE TRUNK¿IPSILATERAL LEG ENDOPROSTHESIS, ONE CONTRALATERAL LEG ENDOPROSTHESIS, ONE ILIAC EXTENDER AND ONE ILIAC BRANCH ENDOPROSTHESIS. AN INTERNAL ILIAC COMPONENT WAS REPORTED AS PART OF THE COMPLAINT BUT THE COMPONENT WAS NOT RETURNED. ALL NOTED TRANSECTIONS WERE MADE PRIOR TO ARRIVAL AT W.L. GORE & ASSOCIATES, INC. EXCEPT WHERE NOTED AS OBTAINED FOR HISTOPATHOLOGICAL ANALYSIS. THE LUMENS OF ALL DEVICE FRAGMENTS/ ILIAC EXTENDER WERE WIDELY PATENT. MULTIFOCAL, FIBROCOLLAGENOUS FLAT THIN LAYERED, LIGHT TAN TO BROWN TISSUE WAS FIRMLY ADHERED TO THE ABLUMINAL SURFACE OF ALL OVERLAPPING DEVICE FRAGMENTS AND AN ILIAC EXTENDER. MULTIFOCAL, FIBROCOLLAGENOUS FRIABLE FLAT THIN LAYERED LIGHT TAN TO BROWN TISSUE WAS LOOSELY ADHERED TO THE LUMINAL SURFACE OF ALL DEVICE FRAGMENTS/ ILIAC EXTENDER. THE ILIAC EXTENDER WAS THE ONLY INTACT DEVICE ALL OTHERS WERE TRANSECTED BY SHARP SURGICAL INSTRUMENTATION, PRIOR TO ARRIVAL DURING THE EXPLANT PROCEDURE. THE CONTRALATERAL LEG ENDOPROSTHESIS WAS SEATED WITHIN THE TRUNK AND THE ILIAC BRANCH ENDOPROSTHESIS IN AN OVERLAPPING CONFIGURATION. HISTOPATHOLOGICAL EXAMINATION OF EIGHT SPECIMENS, (THREE ABLUMINAL AND TWO LUMINAL TISSUE SPECIMENS, AND THREE MATERIAL SPECIMENS) WAS PERFORMED. ALTHOUGH NO INFECTIOUS AGENTS WERE OBSERVED BY MICROSCOPIC EVALUATION OF STAINED TISSUES SECTIONS (I.E. H&E, MASSON¿S TRICHROME, MOVAT PENTACHROME, AND GRAM STAIN), THERE WERE ABLUMINAL TISSUE SECTIONS WHICH CONTAINED AN ACUTE INFLAMMATORY INFILTRATE MOST CONSISTENT WITH A BACTERIAL INFECTION. ALL OTHER MICROSCOPIC OBSERVATIONS WERE EXPECTED AND WITHIN THE PARAMETERS OF NORMAL HEALING AROUND A MEDICAL DEVICE. THE DEVICE FRAGMENTS/ ILIAC EXTENDER WERE SUBJECTED TO AN ENZYMATIC DIGESTION PROCESS TO REMOVE BIOLOGIC DEBRIS. FOLLOWING DIGESTION ALL DEVICES WERE EXAMINED FOR MATERIAL DISRUPTIONS WITH THE AID OF A STEREOMICROSCOPE AND SCANNING ELECTRON MICROSCOPY (SEM). MULTIPLE AREAS OF GRAFT MATERIAL DISRUPTION WERE NOTED THAT EXHIBITED DARK, CHARRED, EDGES, CONSISTENT WITH ELECTROCAUTERY MARKS WHICH WAS USED DURING THE EXPLANT PROCEDURE. THE EXTERNAL ILIAC LEG OF THE ILIAC BRANCH ENDOPROSTHESIS PRESENTED TWO AREAS WITH WEAR RELATED HOLES, AT ADJACENT APICES. MATERIAL CHARACTERISTICS (GRAFT CURVE) IN CONJUNCTION WITH CT IMAGING SUGGESTS THE POSITIONING OF THE HOLES WAS AT A SITE OF AN ANATOMICAL BEND IN VASCULATURE. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO FEVER AND INFECTION (E.G., ANEURYSM, DEVICE OR ACCESS SITES) AND SURGICAL CONVERSION. THE FOLLOW UP MEDWATCH#: 3007284313-2017-00287 WAS SUBMITTED TO FDA TO COVER GORE® EXCLUDER® AAA ENDOPROSTHESES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: EVENT DESCRIPTION. DEVICE IS AVAILABLE FOR EVALUATION, RETURNED DATE. THE EXPLANT EVALUATION IS IN PROCESS. FURTHER INFORMATION WILL BE PROVIDED. ALSO WERE INVOLVED RLT261416/13610331, PLC271200/13654572 AND PXL161407/13445468. THE FOLLOW UP MEDWATCH# 3007284313-2017-00287 WAS SUBMITTED TO FDA TO COVER THESE DEVICES.

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING AND THE STERILIZATION PAPERWORK VERIFIED THAT THESE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4). ALSO WAS INVOLVED: (B)(4). REFER TO FIELD FOR THE RESULTS OF THE IMAGING EVALUATION. (B)(4). ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO FEVER AND INFECTION (E.G., ANEURYSM, DEVICE OR ACCESS SITES). ALSO WERE INVOLVED RLT261416/13610331, PLC271200/13654572 AND PXL161407/13445468. THE MEDWATCH# 3007284313-2017-00287 WAS SUBMITTED TO FDA TO COVER THESE DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE PATIENT WAS CONVERTED TO OPEN REPAIR AND ALL INFECTED DEVICES HAVE BEEN EXPLANTED. THE DECISION WAS MADE TO PERFORM AN AORTOBIFEMORAL BYPASS. REPORTEDLY, EXTENSIVE HISTORY AND PHYSICAL AS WELL AS WORKUP DID NOT REVEAL ANY SOURCE OF THIS INFECTION. IT WAS REPORTED THAT THE PATIENT WAS ON ICU CARE POST OP FROM (B)(6) 2017 TO (B)(6) 2017. REQUIRED BP SUPPORT POST OP + 2 U PRBC ON POD#1 ( ALSO RECEIVED 4UPRBC DURING OPERATION); EXTUBATED 1 DAY POST OP, TRANSFERRED TO VASCULAR SURGERY STEP DOWN UNIT FROM ICU ON (B)(6) 2017, ADDITIONAL TRANSFUSION ON TO (B)(6) 2017 AND (B)(6) 2017 SECONDARY TO HCT 22. , HAS POST OP ILEUS, SOME PAIN MANAGEMENT ISSUES SECONDARY TO LARGE INCISIONAL AREA, PAIN CONTROL IMPROVED PER PAIN MANAGEMENT TEAM AS OF (B)(6) 2017. THE PATIENT REMAINED ON TRIPLE ANTIBIOTICS. INFECTIOUS DISEASE TEAM FELT THAT INFECTION WAS BEING MANAGED WITH PRESENT REGIME.

    Description of Event or Problem · 1

    ON (B)(6) 2015 A PATIENT UNDERWENT TREATMENT OF ABDOMINAL AND COMMON ILIAC AORTIC ANEURYSMS WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE). ON (B)(6) 2017, THE PATIENT EXPERIENCED FEVER WITH POSSIBLE GRAFT INFECTION (UNKNOWN CAUSE) AND UNDERWENT IV VANCOMYCIN AND PIPERACILLIN ANTIBIOTIC TREATMENT. WHITE BLOOD CELL (WBC) COUNT WAS ELEVATED (11.2). BLOOD CULTURES TAKEN SHOWED NO GROWTH TO DATE. ADDITIONALLY CT IMAGES SHOWED A CONCERN FOR GRAFT INFECTION. ON (B)(6) 2017 THE WBC COUNT HAD DECREASED TO 9.7. THE BLOOD ANCA TEST USED TO RULE OUT IMMUNE DISORDERS WAS NEGATIVE. ON (B)(6) 2017 THE WBC COUNT WAS 9.9. ON (B)(6) 2017 THE FEVER SUBSIDED, BUT THE PATIENT WAS HAVING MORE ABDOMINAL PAIN. HE COMPLAINED OF LOWER BACK PAIN AND HEADACHE, HOWEVER THERE IS NO NEUROVASCULAR DEFICIT. THE ASSESSMENT INCLUDED CONCERN ABOUT THE DEVELOPMENT OF AN AORTO-ENTERIC FISTULA. A PLAN WAS MADE TO CONTINUE IV ANTIBIOTICS FOR 6 WEEKS, THEN POSSIBLY EXPLANT THE GRAFTS OR CONTINUE SUPPRESSIVE ANTIBIOTICS. ON (B)(6) 2017 A CTA OF THE ABDOMEN AND PELVIS WAS PERFORMED. THE SUMMARY OF FINDINGS STATED THERE REMAINS CONCERN FOR GRAFT INFECTION. THERE WAS NO PERIAORTIC FLUID COLLECTION OR LEAK SEEN. THE RIGHT ILIAC ANEURYSM HAD INCREASED IN SIZE FROM 5.2CM ON (B)(6) 2017 TO 5.4CM. THICKENING OF THIS SAC WALL WAS ALSO NOTED. LABORATORY VALUES ON THIS DATE RELATED TO INFECTION INCLUDED AN ELEVATED C-REACTIVE PROTEIN LEVEL OF 176.6. ON (B)(6) 2017, THE PATIENT WAS FEELING BETTER EXCEPT FOR MILD HEADACHE, HOWEVER THE WBC COUNT WAS 11.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839298 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 11855027

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| O