BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® PROPATEN® VASCULAR GRAFT

    MDR report key: 11313502 · Received February 11, 2021

    Report

    Report Number
    2017233-2021-01663
    Event Type
    Injury
    Date Received
    February 11, 2021
    Date of Event
    November 17, 2020
    Report Date
    October 5, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED TO SECTION C1: SUSPECT PRODUCTS: NAME: CBAS® HEPARIN SURFACE. MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT NUMBER: 6670923PP002.

    Additional Manufacturer Narrative · 0

    EXPLANT INVESTIGATION: THE DEVICE WAS RETURNED TO GEPROVAS FOR INVESTIGATION. SUBMITTED IN FORMALIN WAS ONE GORE® PROPATEN® VASCULAR GRAFT FRAGMENT. THE SCOPE AND RESULTS OF THE INVESTIGATION WERE SUMMARIZED, AND A REPORT WAS SUBMITTED TO W. L. GORE & ASSOCIATES. AN EXPLANT SCIENTIST AT W. L. GORE & ASSOCIATES REVIEWED THE REPORT AND PERFORMED IN PERSON ON-SITE EVALUATION OF THE SPECIMEN. EXPLANT SCIENTIST OBSERVATIONS: THE GRAFT FRAGMENT WAS REPORTED TO MEASURE 120 MM IN LENGTH WITH BOTH ENDS TRANSECTED. THE ABLUMEN WAS ENCASED IN LIGHT TAN/TAN TISSUE WITH MULTIFOCAL DEPOSITS YELLOW (PRESUMED ADIPOSE) TISSUE. BLUE ALIGNMENT MARKS WERE FAINTLY VISIBLE ON INSPECTION. THE LUMEN OF EXTREMITY A WAS OCCUPIED WITH GELATINOUS BROWN TISSUE. EXTREMITY B WAS LIGATED WITH MULTIFILAMENT BLUE-GREEN SUTURE IN A CONTINUOUS RUNNING PATTERN. THE GRAFT FRAGMENT WAS NOT PATENT. REASON: BASED ON THE EXPLANT SCIENTIST¿S REVIEW OF THE GEPROVAS REPORT, NO ADDITIONAL ANALYSIS IS REQUESTED. THE REPORTED REASON FOR REMOVAL WAS INFECTION WITH NO ACCUSATION OF INFECTION BEING DEVICE RELATED FROM THE PHYSICIAN. THE ORIGIN OF INFECTION CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED NOR VIA THE ANALYSES AVAILABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT HISTORY REVIEW: A REVIEW OF THE STERILIZATION RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    H6 EVALUATION CODES INVESTIGATION FINDINGS 213 REFERS TO THE PHR-REVIEW: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE RELEASED PORTION OF THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ANALYSIS-REPORT FROM THIRD PARTY WAS RECEIVED AND WILL BE FURTHER INVESTIGATED.

    Additional Manufacturer Narrative · 1

    ANALYSIS-REPORT FROM THIRD PARTY WAS RECEIVED AND WILL BE FURTHER INVESTIGATED. CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE THAT PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A RIGHT-LEFT CROSSED FEMORO-FEMORAL BYPASS WITH A GORE® PROPATEN® VASCULAR GRAFT - THIN-WALLED REMOVABLE RINGED. IT WAS STATED THAT THE PROSTHESIS WAS IMPLANTED ON (B)(6) 2020 IN ORDER TO TREAT AN ACUTE ISCHEMIA OF THE LEFT LOWER LIMB FOLLOWING THE TREATMENT OF A TYPE A AORTIC DISSECTION BY OPEN SURGERY. IT WAS REPORTED THAT ON (B)(6) 2020, AFTER ABOUT 2 MONTHS, THE DISTAL PART OF THE PROSTHESIS WAS EXPLANTED DUE TO A RUPTURE OF THE DISTAL ANASTOMOSIS (CASE (B)(4)). IT WAS STATED THAT 6 DAYS LATER, THE REST OF THE PROSTHESIS WAS EXPLANTED DUE TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212268 GORE® PROPATEN® VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention