BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX® STRETCH VASCULAR GRAFT

    MDR report key: 19545255 · Received June 17, 2024

    Report

    Report Number
    2017233-2024-05038
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    January 30, 2024
    Report Date
    July 5, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    UDI-DI
    00733132612383
    PMA / PMN Number
    K933943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. PRODUCT HISTORY REVIEW: A MANUFACTURING RECORDS AND STERILIZATION RECORDS REVIEW IS BEING PERFORMED. H3: OTHER CODE: THE MEDICAL DEVICE RETURNED TO A THIRD PARTY FOR FURTHER INVESTIGATION. THE ANALYSIS REPORT WAS SHARED WITH GORE AND WAS EVALUATED APPROPRIATELY. AN EXPLANT INVESTIGATOR (EI) AT W.L. GORE & ASSOCIATES HAS REVIEWED THE REPORT. EXPLANT SCIENTIST OBSERVATIONS: THE ABLUMINAL SURFACE WAS GENERALLY DEVOID OF TISSUE. EXTREMITY A WAS TRANSECTED IN AN IRREGULAR, BEVELED MANNER WITH DISCONTINUOUS FRAGMENTS OF BLUE MONOFILAMENT SUTURE PRESENT. EXTREMITY B WAS TRANSECTED AND HAD DARK RED/BROWN TISSUE PRESENT WITHIN THE LUMEN. THE LUMINAL PATENCY OF THE GRAFT FRAGMENT COULD NOT BE DETERMINED WITH THE INFORMATION/IMAGES PROVIDED. NEAR EXTREMITY A, AN AREA WITH A MISSING RING AND A BLUE MONOFILAMENT SUTURE THROW WAS PRESENT. THE TRANSECTIONS WERE CONSISTENT WITH THOSE CAUSED BY CUTTING WITH SHARP SURGICAL INSTRUMENTATION (I.E., SCALPEL/SCISSORS), WHICH WERE LIKELY USED DURING A SURGICAL PROCEDURE. THE EXACT TIME AND CAUSE OF THE RING DISPLACEMENT AND BLUE MONOFILAMENT SUTURE COULD NOT BE DETERMINED WITH THE INFORMATION/IMAGES PROVIDED. MATERIAL DISRUPTIONS (E.G., TRANSECTIONS) WERE CONSISTENT WITH THOSE CAUSED BY SURGICAL INSTRUMENTATION (E.G., SCALPEL, SCISSORS), WHICH LIKELY OCCURRED DURING A SURGICAL PROCEDURE. BASED ON THE EXPLANT SCIENTIST¿S REVIEW OF THE GEPROMED REPORT, NO ADDITIONAL ANALYSIS IS REQUESTED. IN THE INSTRUCTION FOR USE FOR THE GORE-TEX® STRETCH VASCULAR GRAFT THE FOLLOWING IS STATED: ADVERSE EVENTS POTENTIAL DEVICE AND PROCEDURE-RELATED ADVERSE EVENT 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 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT SURGICAL TREATMENT FOR AN ACUTE ISCHEMIA IN THE LEFT LOWER LIMB WITH A GORE-TEX® STRETCH VASCULAR GRAFT - THIN-WALLED REMOVABLE RINGED. THE PROSTHESIS WAS IMPLANTED ON (B)(6) 2023, AS A BYPASS BETWEEN THE SUPRA-ARTICULAR POPLITEAL ARTERY AND THE SUB-ARTICULAR POPLITEAL ARTERY OF THE LEFT LOWER LIMB IN ORDER TO TREAT AN ACUTE ISCHEMIA WITH SENSITIVOMOTOR DISORDERS. AN ABSCESS WAS NOTED ON THE POPLITEAL FOSSA. ON (B)(6) 2024, AFTER APPROXIMATELY 1 MONTH, THE PROSTHESIS WAS EXPLANTED DUE TO A PSEUDOMONAS INFECTION. DURING THE SAME PROCEDURE, A FEMOROPOPLITEAL BYPASS USING AN ARTERIAL ALLOGRAFT WAS IMPLANTED. THE PATIENT WAS AUTHORISED TO RETURN HOME ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337753 GORE-TEX® STRETCH VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W. L. GORE & ASSOCIATES, INC. 00733132612383

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention