BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 8708268 · Received June 18, 2019

    Report

    Report Number
    2017233-2019-00441
    Event Type
    Injury
    Date Received
    June 18, 2019
    Date of Event
    May 22, 2019
    Report Date
    November 18, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: C1. NAME (#1) - CBAS® HEPARIN SURFACE; MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT #5773281PP021. CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B1: ADVERSE EVENT AND/OR PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: A GORE® PROPATEN® VASCULAR GRAFT WAS IMPLANTED TO REPLACE AN INFECTED PORTION OF A NON-GORE VASCULAR GRAFT (RIGHT FOREARM BRACHIAL ARTERY- BASILICA VEIN OF FOREARM LOOP SHUNT) ON (B)(6) 2018. THE FOLLOWING INFORMATION REGARDING THIS EVENT WAS PROVIDED TO W. L. GORE & ASSOCIATES: ON (B)(6) 2017, THE PATIENT RECEIVED A NON-GORE VASCULAR GRAFT IN THE RIGHT FOREARM FOR SHUNT CONSTRUCTION. (RIGHT FOREARM BRACHIAL ARTERY- BASILIC VEIN OF FOREARM LOOP SHUNT). ON (B)(6) 2018, INFECTION WAS SUSPECTED OF THE NON-GORE VASCULAR GRAFT, SO THE LOOP PART WAS PARTIALLY REMOVED AND REPLACED WITH THE GORE® PROPATEN® VASCULAR GRAFT WITH INTEGRATED RINGS (IRH061020J/ 5773281PP021) AT KAIKOUKAI CENTRAL CLINIC. ON (B)(6) 2019, IN THE EVENING OF A DIALYSIS DAY IN NAGOYA EISEIKAI HOSPITAL, OCCLUSION IN A PART OF THE GORE® PROPATEN® VASCULAR GRAFT WAS IDENTIFIED. THE OCCLUDED SECTION WAS REMOVED AND REPLACED WITH A NON-GORE VASCULAR GRAFT. SINCE A DETERIORATION OF THE GRAFT WAS OBSERVED, IT WAS CONCLUDED THAT OCCLUSION WAS THE CAUSE. THOUGH, THE PHYSICIAN REPORTED TO BELIEVE THAT THE DETERIORATION OF THE GORE® PROPATEN® VASCULAR GRAFT WAS CAUSED WHEN PTA BALLOONING WAS PERFORMED, THIS AREA WAS PUNCTURED AS THE SHEATH APPROACHED. AT THE TIME OF EVENT REPORTING, THE PATIENT WAS STILL HOSPITALIZED. THE GRAFT FRAGMENTS WERE RETURNED TO W. L. GORE & ASSOCIATES FOR INVESTIGATION. SUBMITTED IN FORMALIN WERE TWO GORE® PROPATEN® VASCULAR GRAFT FRAGMENTS AND ONE NON-GORE VASCULAR GRAFT FRAGMENT, PRESUMED INTERGARD REINFORCED VASCULAR GRAFT. DEVICE FRAGMENTS HAD BEEN TRANSECTED PRIOR TO ARRIVAL AT W. L. GORE AND ASSOCIATES. THE NON-GORE GRAFT WAS NOT EVALUATED AS PART OF THIS EVENT. THE FRAGMENTS WERE GENERALLY DEVOID OF TISSUE EXCEPT ABLUMINAL SCANT FOCI OF WHITE AND TAN-BROWN SOFT TISSUE. SPECIMEN #2 PRESENTED IN A FLATTENED CONFIGURATION. THE LUMEN OF SPECIMEN #1 WAS WIDELY PATENT. THE GRAFT MATERIAL WAS SEVERELY DISRUPTED, CONSISTING OF TRANSMURAL COALESCING AND ELONGATED HOLES; PRIMARILY ALONG THE ALIGNMENT MARKS AND EXTENDING IN MULTIPLE DIRECTIONS. AREAS OF RADIAL FILM DISPLACEMENT AND ABSENCE WERE PRESENT THROUGHOUT THE FRAGMENT AND MULTIPLE EVENLY SPACED SERRATION MARKS WERE PRESENT ON THE ABLUMINAL SURFACE. HISTOPATHOLOGICAL EXAMINATION OF TWO GRAFT AND TISSUE SPECIMENS WAS PERFORMED. THE EXAMINED SECTIONS OF A GORE® PROPATEN® VASCULAR GRAFT EXHIBITED THE NORMAL HEALING TRAITS OF AN OUTER COVERING OF MATURE FIBROUS CONNECTIVE TISSUE WITH MINIMAL FOREIGN BODY INFLAMMATORY RESPONSE. THE SECTIONED LUMINA WERE WIDELY PATENT WITH ONLY A THIN LAYER OF UNORGANIZED FIBRIN THROMBUS PRESENT. INFECTIOUS AGENTS WERE NOT OBSERVED. THE GRAFT FRAGMENTS 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. DISRUPTIONS IDENTIFIED WERE NOT ASSOCIATED WITH HANDLING OR MANUFACTURING PROCESS AT W.L. GORE & ASSOCIATES. THE DISRUPTIONS ARE CONSISTENT WITH A SURGICAL PROCEDURE, CANNULATION AND AN ACUTE TENSION EVENT(S). MATERIAL DISRUPTIONS ASSOCIATED WITH MULTIPLE MODALITIES ARE PRESENT IN THIS CASE: THE FRAGMENT WAS MODERATELY CANNULATED WITH SITES CONCENTRATED ALONG THE ALIGNMENT MARKERS, IT WAS REPORTED THAT THE RETURNED SEGMENT OF THE GRAFT WAS PUNCTURED DURING A PTA BALLOONING PROCEDURE, AND THE GRAFT WAS MANUALLY MANIPULATED, PRESUMED AT THE TIME OF EXPLANT, AS IS EVIDENT BY THE COMBINATION OF SURGICAL CLAMP MARKS AND DISPLACED RADIAL FILM. THE TEARING OF THE GRAFT MATERIAL COULD PRESUMABLY BE CAUSED BY ONE OR MULTIPLE OF THESE DISRUPTIONS, THUS PRECISE MODALITY CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT MET RELEASE REQUIREMENTS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2017, THE PATIENT RECEIVED A NON-GORE VASCULAR GRAFT IN THE RIGHT FOREARM FOR SHUNT CONSTRUCTION (RIGHT FOREARM BRACHIAL ARTERY- BASILIC VEIN OF FOREARM LOOP SHUNT). ON (B)(6) 2018, INFECTION WAS SUSPECTED OF THE NON-GORE VASCULAR GRAFT, SO THE LOOP PART WAS PARTIALLY REMOVED AND REPLACED WITH THE GORE® PROPATEN® VASCULAR GRAFT WITH INTEGRATED RINGS (IRH061020J/ 5773281PP021). ON (B)(6) 2019, OCCLUSION WAS IDENTIFIED WITHIN THE GORE® PROPATEN® VASCULAR GRAFT. THE OCCLUDED SECTION WAS REMOVED AND REPLACED WITH A NON-GORE VASCULAR GRAFT. DETERIORATION OF THE REMOVED PORTION OF GORE® PROPATEN® VASCULAR GRAFT SECTION WAS OBSERVED. THE DOCTOR SPECULATED THAT DETERIORATION OF THE GORE® PROPATEN® VASCULAR GRAFT WAS CAUSED WHEN PTA BALLOONING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502873 GORE PROPATEN VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 5773281PP021

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention