BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 10917157 · Received November 30, 2020

    Report

    Report Number
    2017233-2020-01492
    Event Type
    Injury
    Date Received
    November 30, 2020
    Date of Event
    October 16, 2020
    Report Date
    May 26, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6 EVALUATION CODES INVESTIGATION FINDINGS 213 REFERS TO THE PHR-REVIEW. PHR-REVIEW: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. EXPLANT INVESTIGATION: THE DEVICE FRAGMENT WAS RETURNED TO W. L. GORE & ASSOCIATES FOR INVESTIGATION. SUBMITTED UNFIXED WAS A GORE PROPATEN VASCULAR GRAFT FRAGMENT (VGF). THE ABLUMINAL SURFACE WAS GENERALLY DEVOID OF SOFT TISSUE. SCANT, MINIMAL, BLACK SOFT TISSUE WAS PRESENT IN THE LUMEN. THE LUMEN WAS PATENT. VGF HAD BEEN TRANSECTED AT BOTH EXTREMITIES, PRIOR TO ARRIVAL AT W. L. GORE & ASSOCIATES. HISTOPATHOLOGIC ANALYSIS WAS NOT PERFORMED, DUE TO THE LACK OF TISSUE ON VGF AND THE LACK OF PROPER FIXATION PRIOR TO ARRIVAL AT W. L. GORE & ASSOCIATES. VGF WAS SUBJECTED TO AN ENZYMATIC DIGESTION PROCESS TO REMOVE BIOLOGIC DEBRIS. FOLLOWING DIGESTION, VGF WAS EXAMINED FOR MATERIAL DISRUPTIONS WITH THE AID OF A STEREOMICROSCOPE. THE LONGITUDINAL REINFORCEMENT FILM, WITH ATTACHED RINGS, WAS PRESENT AROUND THE BASE TUBE, BUT NOT ATTACHED TO THE BASE TUBE; WRAP AND RINGS WERE ABLE TO SLIDE FREELY OVER BASE TUBE. MULTIPLE AREAS WITH HOLES IN THE RADIAL FILM WRAP WERE PRESENT FROM THE PROXIMAL EXTREMITY TO APPROXIMATELY MID-GRAFT. THE MAJORITY OF THE BASE TUBE WAS IN-FOLDING IN A ¿V-SHAPE¿, DUE TO THE LONGITUDINAL REINFORCEMENT FILM AND RINGS NO LONGER BEING ATTACHED TO THE BASE TUBE. THE UNATTACHED FILM AND HOLES WERE LIKELY CAUSED BY MECHANICAL MANIPULATION OF THE GRAFT (I.E., TUNNELING), LIKELY USED DURING A SURGICAL PROCEDURE. DISRUPTIONS IDENTIFIED WERE NOT ASSOCIATED WITH HANDLING OR MANUFACTURING PROCESS AT W.L. GORE & ASSOCIATES. THE DISRUPTIONS ARE CONSISTENT WITH A SURGICAL PROCEDURE. 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 · 1

    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 BELOW KNEE BYPASS WITH A GORE® PROPATEN® VASCULAR GRAFT - THIN-WALLED REMOVABLE RINGED (PROPATEN-DEVICE). IT WAS STATED THAT THE PHYSICIAN COULD NOT SEE ANY DAMAGE WHEN THE PROPATEN-DEVICE WAS TAKEN OUT OF THE PACKAGE AND NO SPECIAL FRICTION COULD BE OBSERVED DURING THE SUCCESSFUL IMPLANTATION. IT WAS REPORTED THAT 3 DAYS LATER THE PHYSICIAN FOUND THE PROPATEN-DEVICE TO BE CLOSED. IMMEDIATELY HE CUT OFF THE DAMAGED PART OF THE PROSTHESIS AND REPLACED IT WITH ANOTHER SHORTER RINGED DEVICE. IT WAS STATED THAT THE EXPLANTED PROSTHESIS SHOWS SOME DISLOCATED RINGS WHICH HAVE BEEN PLACED DIRECTLY ACROSS THE KNEE. THERE WAS NO REPORT OF ANY MECHANICAL OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382096 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 79 YR Required Intervention