BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 11852696 · Received May 19, 2021

    Report

    Report Number
    3007284313-2021-01434
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    April 27, 2021
    Report Date
    August 3, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622528
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    G1. MANUFACTURING SITE NAME AND ADDRESS: MEDICAL PHOENIX 2 32470 N NORTH VALLEY PKWY PHOENIX, AZ 85085.

    Additional Manufacturer Narrative · 0

    THE IMAGES WERE RECEIVED FOR ANALYSIS. PLEASE SEE B6 FOR IMAGING EVALUATION FINDINGS.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. HOWEVER, THE ENGINEERING EVALUATION WAS PERFORMED BASED ON THE INFORMATION PROVIDED. WITHOUT A PHYSICAL SAMPLE OR IMAGES, THE PHYSICIAN¿S OBSERVATION THAT ¿AFTER DEPLOYMENT IT WAS NOTED THAT THE GATE APPEARED TO NOT HAVE OPENED¿, COULD NOT BE EVALUATED. THE LIKELY CAUSE FOR THE REPORTED OBSERVATION THAT THE GATE DID NOT APPEAR TO OPEN FOLLOWING FIRST DEPLOYMENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. HOWEVER, IT IS UNLIKELY THAT THE REPORTED ROTATION AND DEVICE MANIPULATION WITHIN THE SHEATH LED TO THE GATE NOT APPEARING TO OPEN FOLLOWING FIRST DEPLOYMENT. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), THE GORE® EXCLUDER® AAA ENDOPROSTHESIS IS INTENDED TO EXCLUDE THE ANEURYSM FROM THE BLOOD CIRCULATION IN PATIENTS DIAGNOSED WITH INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) DISEASE AND WHO HAVE APPROPRIATE ANATOMY INFRARENAL AORTIC NECK TREATMENT DIAMETER RANGE OF 19 ¿ 32 MM AND A MINIMUM AORTIC NECK LENGTH OF 15 MM. THE SAFETY AND EFFECTIVENESS OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS HAVE NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH LESS THAN 15 MM IN LENGTH OF THE PROXIMAL AORTIC NECK. KEY ANATOMIC ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE SHORT PROXIMAL AORTIC NECK AND SIGNIFICANT THROMBUS AND / OR CALCIUM AT THE ARTERIAL IMPLANTATION SITES, SPECIFICALLY THE PROXIMAL AORTIC NECK. ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE BUT ARE NOT LIMITED TO PATIENT¿S ANATOMICAL SUITABILITY FOR ENDOVASCULAR REPAIR. ADDITIONALLY, THE IFU STATES: DO NOT ROTATE THE TRUNK, CONTRALATERAL LEG, ILIAC EXTENDER, OR AORTIC EXENDER DELIVERY CATHETER WHILE THE ENDOPROSTHESIS IS INSIDE THE INTRODUCER SHEATH. CATHETER BREAKAGE OR SEPARATION OR PREMATURE DEPLOYMENT HAVE OCCURRED AND MAY RESULT IN POTENTIAL PATIENT HARMS. VERIFY THAT THE GUIDEWIRE IS WITHIN THE CONTRALATERAL LEG HOLE OF THE TRUNK BY STANDARD PRACTICE USED TO VERIFY GUIDEWIRE LOCATION. IF MULTIPLE CANNULATION ATTEMPTS FAIL, THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS MAY BE REPOSITIONED FOR BETTER CONTRALATERAL GATE ACCESS. DO NOT CONSTRAIN / REOPEN THE TRUNK DEVICE MORE THAN TWO TIMES DURING A PROCEDURE. DEVICE AND / OR CATHETER DAMAGE MAY OCCUR. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO INCOMPLETE COMPONENT DEPLOYMENT

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND A GORE®EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC AND AN ILIAC ARTERY ANEURYSM. REPORTEDLY, THE PATIENT¿S THE ANATOMY WAS OUTSIDE OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) AND THE ATTENDING GORE CLINICAL SPECIALIST DISCUSSED THIS WITH THE PHYSICIAN PRIOR TO THE PROCEDURE. THE AORTIC NECK WAS NARROW AND SHORT (12MM) AND HAD SOME THROMBUS. AFTER ADVANCEMENT OF THE ILIAC BRANCH ENDOPROSTHESIS, THE TRUNK IPSILATERAL ENDOPROSTHESIS WAS ADVANCED VIA THE LEFT FEMORAL ARTERY THROUGH AN 18FR GORE® DRYSEAL FLEX INTRODUCER SHEATH OVER A LUNDERQUIST WIRE. REPORTEDLY, AGAINST THE ADVICE OF THE ATTENDING GORE CLINICAL SPECIALIST, THE DEVICE WAS PUSHED AND PULLED WITHIN THE SHEATH TO ROTATE THE CONTRALATERAL GATE TO THE DESIRED LOCATION BEFORE UNSHEATHING THE DEVICE. THE SHEATH WAS RETRACTED AND THE OUTER WHITE KNOB OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3®DELIVERY SYSTEM WAS PULLED TO DEPLOY THE GATE OF THE TRUNK IPSILATERAL ENDOPROSTHESIS. AFTER DEPLOYMENT IT WAS NOTED THAT THE GATE APPEARED TO NOT HAVE OPENED. THE REMAINDER OF THE TRUNK IPSILATERAL ENDOPROSTHESIS WAS DEPLOYED AND THE GATE OPENED A LITTLE MORE BUT NOT FULLY. BRACHIAL ACCESS WAS OBTAINED FOR PROTECTION OF THE RIGHT RENAL ARTERY STENT IN SITU. MULTIPLE ATTEMPTS WITH RETROGRADE AND ANTEGRADE APPROACH WERE MADE TO CANNULATE THE GATE USING THE 0.018" WIRE AND BALLOONS WITH NO SUCCESS. IT WAS REPORTED THAT AN 8MM X 80MM 0.035" BALLOON WAS USED TO FACILITATE THE WIRE EXCHANGE TO A LUNDERQUIST WIRE AND ADVANCE THE 16FR SHEATH INTO THE CONTRALATERAL GATE OF THE TRUNK IPSILATERAL ENDOPROSTHESIS. THE PROCEDURE WAS COMPLETED. ALL DEVICES WERE SUCCESSFULLY IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN FELT THAT THE CANNULATION ISSUE WAS DUE TO DEVICE ROTATION AND MANIPULATION WITHIN THE SHEATH. REPORTEDLY, NO RESISTANCE WAS NOTED. THE PATIENT¿S ANATOMY WASN¿T THE MAIN REASON AS IN THE FIRST DEPLOYMENT THE DISTAL END OF THE GATE WAS NOT OPENED. THIS PROXIMAL NARROWING MADE IT MORE DIFFICULT FOR CANNULATION BUT NOT COMPLETELY FOR GATE OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746771 GORE EXCLUDER AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. RLT281412 00733132622528

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR CEB231410, PLC271000, PLC201000, BXAL085902B.