BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 17685914 · Received September 5, 2023

    Report

    Report Number
    3007284313-2023-02737
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 9, 2023
    Report Date
    September 8, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132628117
    PMA / PMN Number
    K160254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED G3/G4, H1/H2, H6. H6: CODE C19 - A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE), GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® DRYSEAL FLEX INTRODUCER SHEATH TO TREAT THE RIGHT COMMON ILIAC ARTERY ANEURYSM AND THE LEFT COMMON ILIAC ARTERY ANEURYSM THAT WAS SUSPECTED BUT NOT DETERMINED, PREOPERATIVELY, IF THE LEFT ANEURYSM SHOULD ALSO BE TREATED AT THE SAME TIME. THE PATIENT HAD PREVIOUSLY UNDERGONE AN ABDOMINAL AORTIC GRAFT REPLACEMENT USING J GRAFT (JAPAN LIFELINE CO., LTD) ON (B)(6), 2016. DURING THE PROCEDURE, A SHEATH WAS DELIVERED FROM PATIENT¿S RIGHT LIMB AND A PULL-THROUGH WIRE WAS FORMED. AN ILIAC BRANCH COMPONENT (IBC, CEB231210A/26688492) WAS THEN DELIVERED FROM THE RIGHT LIMB, AND ITS PROXIMAL PORTION WAS DEPLOYED AT THE RIGHT COMMON ILIAC ARTERY. THE PROXIMAL END OF THE IBC WAS PLACED WITHIN THE J GRAFT. A 12FR 45CM SHEATH WAS THEN DELIVERED FROM PATIENT¿S LEFT LIMB, HOWEVER, THE SHEATH ADVANCEMENT WAS REPORTEDLY DIFFICULT BECAUSE IT WAS DELIVERED WITHIN THE J GRAFT, NOT THE NATIVE VESSEL. BECAUSE OF THE J GRAFT, THE VESSEL WALL WAS LESS SMOOTH THAN THE NATIVE VESSEL AND THE SHEATH WAS MORE PRONE TO GET STUCK INSIDE BUT EVENTUALLY MANAGED TO REACH THE TREATMENT SITE. THE RIGHT IBC WAS FOUND TO HAVE MOVED DISTALLY TO THE ANASTOMOSIS SITE OF THE J GRAFT AND THE IBC LOOKED TO HAVE CONCERTINAED (COMPRESSED INTO FOLDS). THE PHYSICIAN PERFORMED AN ANGIOGRAPHY TO MAKE SURE AN INTERNAL ILIAC COMPONENT (IIC) COULD BE IMPLANTED AS PLANNED. AS NO ISSUES WERE CONFIRMED, THE INTERNAL ILIAC GATE WAS CANNULATED. AN IIC (HGB161007A/26379000) WAS THEN DELIVERED AND DEPLOYED IN THE RIGHT INTERNAL ILIAC ARTERY. A SET OF IBE DEVICES WAS SUCCESSFULLY PLACED ON THE RIGHT SIDE WITHOUT ENDOLEAKS. HOWEVER, THE PHYSICIAN ANTICIPATED A POSSIBLE PROXIMAL TYPE I ENDOLEAK IN THE FUTURE. AS A PREVENTIVE MEASURE, IT WAS DECIDED TO IMPLANT ANOTHER SET OF IBE DEVICES ON THE LEFT SIDE AND EXTEND THE PROXIMAL END OF IBCS ON BOTH SIDES WITH CONTRALATERAL LEG ENDOPROSTHESIS IN A WAY TO LINE THE PREVIOUSLY IMPLANTED J GRAFT. AFTER REPLACING THE 12FR 45CM SHEATH IN THE LEFT LIMB WITH A 16FR SHEATH, A PULL-THROUGH WIRE WAS FORMED, AND ANOTHER IBC (CEB231210A/26688494) WAS DELIVERED TO THE LEFT COMMON ILIAC ARTERY. AFTER DEPLOYING THE PROXIMAL PORTION OF THE IBC, THE PHYSICIAN TRIED TO RE-INSERT THE 12FR 45CM SHEATH INTO THE 16FR SHEATH. AS THE LEADING TIP OF THE DILATOR OF THE 12FR 45CM SHEATH APPEARED TO BE PEELED, THE PHYSICIAN TRIMMED IT WITH SCISSORS BEFORE INSERTION, HOWEVER, THE 12FR 45CM SHEATH COULD NOT BE ADVANCED. ANOTHER 12FR 45CM SHEATH WAS USED AS A REPLACEMENT AND WAS SUCCESSFULLY DELIVERED THROUGH THE 16FR SHEATH. IT WAS THEN FOUND THAT THE LEFT IBC HAD ALSO MOVED DISTALLY TO THE ANASTOMOSIS SITE OF THE J GRAFT. AFTER CANNULATING THE INTERNAL ILIAC GATE, AN IIC (HGB161207A/26312669) WAS DELIVERED AND DEPLOYED IN THE LEFT INTERNAL ILIAC ARTERY. AN ANGIOGRAPHY THEN CONFIRMED THE LEFT SUPERIOR GLUTEAL ARTERY WAS COVERED BY THE DISTAL END OF THE IIC. THE BLOOD FLOW FROM COLLATERAL VESSEL WAS OBSERVED WITHIN THE LEFT SUPERIOR GLUTEAL ARTERY, THEREFORE, NO TREATMENT WAS REQUIRED FOR THE VESSEL COVERAGE. SUBSEQUENTLY, TWO CONTRALATERAL LEG ENDOPROSTHESIS WERE DELIVERED (ONE FROM EACH SIDE OF THE PATIENT, RIGHT AND LEFT) AND DEPLOYED WITHIN THE J GRAFT USING THE KISSING BALLOON TECHNIQUE. THE FINAL ANGIOGRAPHY CONFIRMED NO ISSUES. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, AS THE DSF1245 SHEATH WAS ADVANCED ON BOTH LEFT AND RIGHT SIDES, THE SHEATH WAS CAUGHT ON THE DEPLOYED TRUNK PORTION OF THE IBC DEVICES, THEREFORE, THE PROXIMAL PORTION OF BOTH IBC MOVED DISTALLY ALONG WITH THE SHEATH. THE PHYSICIAN CONSIDERS THAT THE SHEATH DILATOR WAS PEELED AS IT WAS ADVANCED FORCEFULLY WITHIN THE J GRAFT ON THE LEFT LIMB. BECAUSE OF THE PEELED DILATOR TIP, THE SHEATH COULD NOT BE ADVANCED WITHIN THE 16FR SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379655 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. 00733132628117

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention| H