BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® PROPATEN® VASCULAR GRAFT

    MDR report key: 21242741 · Received January 27, 2025

    Report

    Report Number
    2017233-2025-05758
    Event Type
    Injury
    Date Received
    January 27, 2025
    Date of Event
    December 31, 2023
    Report Date
    March 12, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    UDI-DI
    00733132617692
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED D4 -ADDITIONAL UDI NUMBER BASIC UDI-DI (B)(4).

    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

    H6: UPDATED INVESTIGATION CODES: A REVIEW OF THE MANUFACTURING, STERILIZATION, AND BOXING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. NEITHER CLINICAL IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE NOR THE PRODUCT ITSELF WERE RETURNED FOR EVALUATION. NO ITEMS WERE AVAILABLE TO DIRECTLY EVALUATE PRODUCT PERFORMANCE, THEREFORE THE CAUSE OF INFECTION AND REINTERVENTION COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION. THUS, THE INVESTIGATION IS COMPLETE. THE GORE® PROPATEN® VASCULAR GRAFT INSTRUCTION FOR USE (IFU) STATES COMPLICATIONS WHICH MAY OCCUR IN CONJUNCTION WITH THE USE OF ANY VASCULAR PROSTHESIS AND/OR VASCULAR OR RELATED PROCEDURES INCLUDE BUT ARE NOT LIMITED TO: INFECTION; RE-INTERVENTION.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A PATIENT REPORTEDLY UNDERWENT TREATMENT FOR PERIPHERAL ARTERIAL DISEASE (OCCLUDED DISTAL AORTA AND BILATERAL COMMON ILIAC ARTERIES) WITH DEBILITATING SHORT DISTANCE CLAUDICATION AND RIGHT LEG WOUNDS, WHERE A GORE® PROPATEN® VASCULAR GRAFT WAS USED IN AN AXILLO-BIFEMORAL BYPASS WITH BILATERAL FEMORAL ENDARTERECTOMY PROCEDURE. IT WAS ALLEGED THERE WAS NO INFECTION PRESENT AT THE TIME OF THE SURGERY. ON (B)(6), 2023 (53 DAYS POST INITIAL SURGERY), THE PATIENT REPORTEDLY PRESENTED AT THE HOSPITAL WITH PAIN IN LOWER BACK, FEVER, AND SOME DISCHARGE FROM RIGHT GROIN INCISION. ON (B)(6) 2023, THE PATIENT UNDERWENT EMERGENCY EXPLORATORY SURGERY. IT WAS REPORTED, DURING THE PROCEDURE, AN UNINCORPORATED PORTION OF THE GRAFT THAT APPEARED TO BE INFECTED (SIGNS OF PURULENCE AND DISRUPTED SUTURE LINE) WAS EXPLANTED. THE REMAINING GRAFT ON THE RIGHT SIDE AND THE ENTIRE GRAFT ON THE LEFT SIDE OF THE PATIENT WERE NOT EXPLANTED. ON (B)(6) 2024 THE PATIENT WAS REPORTEDLY DISCHARGED AND TRANSFERRED TO ANOTHER FACILITY. ON (B)(6) 2024. THE PATIENT WAS ALLEGEDLY READMITTED TO THE FIRST HOSPITAL AND BLOODWORK CONFIRMED THE PRESENCE OF STAPHYLOCOCCUS AUREUS IN SYSTEM, INDICATING ON-GOING BACTEREMIA. REPORTEDLY, THE PATIENT ALSO HAD SEVER OSTEOMYELITIS IN HER SPINE. ON (B)(6) 2024, THE PATIENT WAS ALLEGEDLY READMITTED TO THE HOSPITAL, REPORTEDLY WITH A HIGH WHITE BLOOD COUNT (WBC). ON (B)(6) 2024, THE PATIENT REPORTEDLY EXPIRED DUE TO ACUTE HYPOXIC RESPIRATORY FAILURE, PULMONARY EDEMA, AND HEART FAILURE REDUCED EJECTION FRACTION. SEPTIC SHOCK WAS LISTED ON THE DEATH CERTIFICATE AS AN 'OTHER SIGNIFICANT CONDITION CONTRIBUTING TO THE DEATH BUT NOT RESULTING IN THE UNDERLYING CAUSE'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758881 GORE® PROPATEN® VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY W. L. GORE & ASSOCIATES, INC. 00733132617692

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention