BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® ACUSEAL VASCULAR GRAFT

    MDR report key: 15891394 · Received November 30, 2022

    Report

    Report Number
    2017233-2022-03521
    Event Type
    Injury
    Date Received
    November 30, 2022
    Date of Event
    October 25, 2022
    Report Date
    January 16, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    PMA / PMN Number
    K130215
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. 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.

    Additional Manufacturer Narrative · 0

    H3 - DEVICE EVALUATED BY MANUFACTURER - YES A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. PRODUCT EVALUATION: THE DEVICE FRAGMENTS WERE RETURNED TO W. L. GORE & ASSOCIATES FOR INVESTIGATION. SUBMITTED IN FORMALIN WAS ONE GORE-TEX STRETCH VASCULAR GRAFT FRAGMENT ATTACHED TO ONE GORE ACUSEAL VASCULAR GRAFT FRAGMENT (VGF-1) VIA GRAFT-TO-GRAFT ANASTOMOSIS AND ONE GORE ACUSEAL VASCULAR GRAFT FRAGMENT (VGF-2). THE DEVICE FRAGMENTS HAD BEEN TRANSECTED PRIOR TO ARRIVAL AT W. L. GORE & ASSOCIATES. THE LUMENS OF BOTH FRAGMENTS WERE WIDELY PATENT. ON VGF-1, THE LUMEN WAS PATENT BUT SIGNIFICANTLY NARROWED THROUGH THE FRAGMENT LENGTH BY BROWN/TAN SOFT TISSUE. ON VGF-2, A VERY SMALL AMOUNT OF GELATINOUS BROWN MATERIAL WAS PRESENT WITHIN THE LUMEN. ALSO, ON VGF-2 NEAR EXTREMITY B, THERE WAS A PARTIALLY CIRCUMFERENTIAL, THIN, TRANSLUCENT MEMBRANE OF INNER EPTFE REFLECTED INTO THE LUMEN. THE ABLUMINAL SURFACES WERE GENERALLY DEVOID OF TISSUE. HISTOPATHOLOGIC ANALYSIS WAS NOT PERFORMED, DUE TO THE LACK OF TISSUE ON THE FRAGMENTS. THE FRAGMENTS WERE SUBJECTED TO AN ENZYMATIC DIGESTION PROCESS TO REMOVE BIOLOGIC DEBRIS. FOLLOWING DIGESTION ALL FRAGMENTS WERE EXAMINED FOR MATERIAL DISRUPTIONS WITH THE AID OF A STEREOMICROSCOPE. OUTER EPTFE AND SILICONE LAYER SEPARATION WAS PRESENT ON BOTH FRAGMENTS AND WAS CONSISTENT WITH SEPARATION CAUSED BY INTERACTION WITH CUTTING AND GRASPING/PULLING WITH SURGICAL INSTRUMENTATION (I.E., FORCEPS/CLAMPS, SCISSORS, SCALPEL), LIKELY USED DURING A SURGICAL PROCEDURE. ON VGF-1, INNER EPTFE AND SILICONE LAYER SEPARATION WAS PRESENT IN AREAS, WHICH WERE LIKELY CAUSED BY SHALLOW-ANGLE CANNULATION EVENTS. CANNULATION MARKS WERE PRESENT WITHIN 2 MM OF THE GRAFT-TO-GRAFT ANASTOMOSIS ON VGF-1. INNER EPTFE AND SILICONE LAYER SEPARATION WAS ALSO PRESENT ON VGF-2. DUE TO THE LIMITED/SHORT LENGTH OF THE FRAGMENT RETURNED AND PRESENCE OF OTHER SURGICALLY INDUCED MATERIAL DISRUPTIONS (E.G., TRANSECTIONS, FORCEPS MARKS) ON VGF-2, THE CAUSE OF THE INNER EPTFE AND SILICONE LAYER SEPARATION COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, A PATIENT WAS IMPLANTED WITH AN ACUSEAL VASCULAR GRAFT (VG) TO TREAT ARTERIOVENOUS FISTULA FROM BRACHIAL ARTERY TO AXILLARY VEIN. THE PATIENT WAS TREATED HEMODIALYSIS THROUGH ACUSEAL VG IN THE EVENING ON THE SAME DAY. ON (B)(6) 2022, PHYSICIAN FOUND THAT THERE WAS THROMBUS THROUGH THE ACUSEAL VG AT PUNCTURE SITE OF HEMODIALYSIS TREATMENT, AND HE SUSPECTED THAT THERE WAS VG DELAMINATION. ON (B)(6) 2022, PHYSICIAN FOUND THAT THERE WAS MORE ORGANIZED THROMBUS AT PUNCTURE SITE OF HEMODIALYSIS TREATMENT. ON (B)(6) 2022, PATIENT WAS DIAGNOSED WITH VG OCCLUSION, THEREFORE, PHYSICIAN PERFORMED SURGERY AND REMOVED ACUSEAL VG. ANOTHER NON-GORE VASCULAR GRAFT WAS USED TO REPLACE THE REMOVED ONE SUCCESSFULLY. PATIENT TOLERATED THE PROCEDURE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6 2022, A PATIENT WAS IMPLANTED WITH AN ACUSEAL VASCULAR GRAFT (VG) TO TREAT ARTERIOVENOUS FISTULA REVISION FROM BRACHIAL ARTERY TO AXILLARY VEIN. THE PATIENT HAD BEEN IMPLANTED WITH A GORE-TEX® STRETCH VASCULAR GRAFT IN MONTHS AGO. PHYSICIAN PERFORMED A JUMPING GRAFT BYPASS WHICH WAS BYPASS ANOTHER GRAFT. ONE END TO END ANASTOMOSIS TO ARTERIAL SIDE AND ANTHER ONE DOING A ANASTOMOSIS TO VENOUS. THE PATIENT WAS TREATED HEMODIALYSIS THROUGH ACUSEAL VG IN THE EVENING ON THE SAME DAY. ON (B)(6) 2022, PHYSICIAN FOUND THAT THERE WAS THROMBUS THROUGH THE ACUSEAL VG AT PUNCTURE SITE OF HEMODIALYSIS TREATMENT, AND HE SUSPECTED THAT THERE WAS VG DELAMINATION. ON (B)(6) 2022, PHYSICIAN FOUND THAT THERE WAS MORE ORGANIZED THROMBUS AT PUNCTURE SITE OF HEMODIALYSIS TREATMENT. ON (B)(6) 2022, PATIENT WAS DIAGNOSED WITH VG OCCLUSION, THEREFORE, PHYSICIAN PERFORMED SURGERY AND REMOVED ACUSEAL VG. A PART OF GORE-TEX® STRETCH VASCULAR GRAFT WAS REMOVED TOGETHER WITH THE ACUSEAL VG VIA A GRAFT-TO-GRAFT ANASTOMOSIS. THERE WAS NO PRODUCT INFORMATION NOR COMPLAINT FOR GORE-TEX® STRETCH VASCULAR GRAFT. ANOTHER NON-GORE VASCULAR GRAFT WAS USED TO REPLACE THE REMOVED ONE SUCCESSFULLY. PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741827 GORE® ACUSEAL VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention