BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 20166351 · Received September 8, 2024

    Report

    Report Number
    2017233-2024-05291
    Event Type
    Injury
    Date Received
    September 8, 2024
    Date of Event
    July 19, 2024
    Report Date
    February 14, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH #2017233-2024-05291 WAS SENT IN ERROR. EVALUATION INCLUDING ADDITIONAL RECEIVED INFORMATION DETERMINED THAT THIS EVENT IS NOT REPORTABLE TO THE FDA AND THEREFORE THE MEDWATCH WILL BE RETRACTED.

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE REMAINS IMPLANTED. RETURN NOT POSSIBLE. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. H6: CODE D12: ACCORDING TO THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: BLEEDING AND/OR HEMATOMA. HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. LITERATURE TITLE: INFECTED SUBCUTANEOUS HEMATOMA IN PERCUTANEOUS DEEP VENOUS ARTERIALIZATION WITH AN OFF-THE SHELF DEVICE AND VENOUS ARTERIALIZATION SIMPLIFIED TECHNIQUE SOURCE: JOURNAL OF CARDIOLOGY CASES 30 (2024) 47¿50. 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.

    Description of Event or Problem · 0

    THE FOLLOWING PUBLICATION WAS REVIEWED BY GORE: TITLE: INFECTED SUBCUTANEOUS HEMATOMA IN PERCUTANEOUS DEEP VENOUS ARTERIALIZATION WITH AN OFF-THE SHELF DEVICE AND VENOUS ARTERIALIZATION SIMPLIFIED TECHNIQUE SOURCE: JOURNAL OF CARDIOLOGY CASES 30 (2024) 47¿50. THIS IS A CASE STUDY PRESENTATION DESCRIBING TREATMENT OF A 65-YEAR-OLD MALE PATIENT WITH NO-OPTION CHRONIC LIMB-THREATENING ISCHEMIA WHO UNDERWENT PERCUTANEOUS DEEP VENOUS ARTERIALIZATION (PDVA). AN ARTERIOVENOUS FISTULA (AVF) WAS CREATED USING A MODIFIED VENOUS ARTERIALIZATION SIMPLIFIED TECHNIQUE. THE ENDOVASCULAR THERAPY INITIALLY AIMED AT RECANALIZING THE ANTERIOR TIBIAL ARTERY (ATA) TO THE DORSAL ARTERY WAS UNSUCCESSFUL. CONSEQUENTLY, WE OPTED TO DILATE THE POSTERIOR TIBIAL ARTERY (PTA) INSTEAD. AMPUTATION OF THE SECOND TO FOURTH TOES WAS SUBSEQUENTLY PERFORMED. HOWEVER, THE WOUNDS DETERIORATED OVER TIME. REVASCULARIZATION FROM THE PTA TO THE PLANTAR ARTERY PROVED TO BE INSUFFICIENT. THEREFORE, PDVA WAS PERFORMED ON THE ATA SIDE. AN ARTERIOVENOUS FISTULA (AVF) WAS CREATED USING A MODIFIED VENOUS ARTERIALIZATION SIMPLIFIED TECHNIQUE (M-VAST). THE ARTERIOVENOUS CONNECTION WAS COMPLETED SUCCESSFULLY. THEN THE 2ND GUIDEWIRE AND FOLLOWING DIAGNOSTIC CATHETER WERE ADVANCED INTO THE VEIN THROUGH THE AVF. TIP INJECTION CONFIRMED THE SUCCESSFUL AVF CROSSING, HOWEVER, BLEEDING FROM THE ARTERIAL PUNCTURE SITE WAS OBSERVED. IT MAY HAVE BEEN CAUSED BY THE BALLOONING OF THE ARTERIAL PUNCTURE SITE. ADDITIONAL BALLOON DILATATION WITH A 5.0 X 100 MM MUSTANG WAS PERFORMED, HOWEVER, BLEEDING CONTINUED. THEREFORE A 5.0 × 250 MM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX DEVICE) WAS DEPLOYED THROUGH THE ATA TO THE ATV TO COVER THE AVF. FINAL ANGIOGRAPHY REVEALED GOOD DVA FLOW. AFTER STENT GRAFT DEPLOYMENT, THE BLEEDING APPEARED TO STOP ACCORDING TO ANGIOGRAPHIC FINDINGS. AFTER THE PROCEDURE, A SUBCUTANEOUS HEMATOMA WAS OBSERVED ON THE PATIENT'S SHIN. HOWEVER, COMPARTMENT SYNDROME DID NOT OCCUR; THEREFORE, CONSERVATIVE THERAPY WAS INITIATED. THE SUBCUTANEOUS HEMATOMA GRADUALLY EXPANDED WHILE THE TOE WOUND STATUS IMPROVED DAILY; HOWEVER, 2 WEEKS AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF PAIN IN THE RIGHT SHIN. ALTHOUGH INFLAMMATORY MARKERS INITIALLY DECREASED AT THE TIME OF THE DVA PROCEDURE, COMPARED TO LEVELS AT ADMISSION, THEY SIGNIFICANTLY INCREASED TWO WEEKS POST-PROCEDURE. HEMATOMA INFECTION WAS SUSPECTED, AND A TEST PUNCTURE WAS PERFORMED ON THE HEMATOMA. DUE TO CLOUDY FLUID FLOWING OUT OF THE NEEDLE, A LARGE ABSCESS WAS SUSPECTED. THEREFORE, INCISIONAL DRAINAGE WAS PERFORMED. A LARGE INCISION WAS MADE, AND EXTENSIVE DEBRIDEMENT WAS PERFORMED, INCLUDING THE SURROUNDING SUBCUTANEOUS TISSUE AND A PORTION OF THE TIBIALIS ANTERIOR MUSCLE. THE CULTURE FROM THE ABSCESS DETECTED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS; THEREFORE, VANCOMYCIN WAS ADDED. WOUND CLEANSING WAS CONTINUED DAILY FOR THE ORIGINAL TOE AND NEW SHIN WOUNDS. THE PATIENT¿S WOUNDS COMPLETELY HEALED APPROXIMATELY 7 MONTHS AFTER THE PDVA. THE PHYSICIAN, (B)(6), STATED THAT THESE EVENTS WERE NOT RELATED TO VSX DEVICE, AS THEY WERE CAUSED BY THE HEMATOMA CREATED BY THE PROCEDURE. IT WAS NOT A DEVICE INFECTION OF THE VSX DEVICE. THEREFORE, THERE WAS NO REMOVAL OF THE VSX DEVICE. THE INFECTION COULD HAVE BEEN CAUSED BY THE HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566422 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention