BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 12447780 · Received September 9, 2021

    Report

    Report Number
    2017233-2021-02345
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    October 22, 2020
    Report Date
    March 17, 2022
    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

    UPDATED ATTACHMENTS. ATTACHED REVIEWED LITERATURE ARTICLE, "A CASE OF STENT-GRAFT IMPLANTATION FOR POSTPANCREATICODUODENECTOMY HEMORRHAGE IN A PATIENT WITH A RECONSTRUCTED GASTRIC TUBE" (B)(6), MD, ET AL. RADIOLOGY CASE REPORTS. 2020 DEC; 15(12): 2710¿2713. PUBLISHED ONLINE 2020 OCT 22.

    Additional Manufacturer Narrative · 0

    AS THE (DEVICES) WHERE OVERLAPPED AND IT IS UNKNOWN WHICH DEVICE(S) MAY HAVE CONTRIBUTED TO THE THROMBOSIS/OCCLUSION/RESTENOSIS, AN ADDITIONAL ( DEVICE ) HAVE BEEN INCLUDED IN THIS REPORT: BOTH GORE® VIABAHN® ENDOPROSTHESIS DEVICES WERE PLACED IN SAME ANATOMICAL LOCATION AT THE SAME TIME. LOT NUMBER AND UDI NUMBER ARE UNKNOWN. LOT NUMBER REQUESTED BUT NOT MADE AVAILABLE. CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM APL, WHICH IN COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY/NON-ELUTING.

    Description of Event or Problem · 0

    THE FOLLOWING LITERATURE WAS REVIEWED. "A CASE OF STENT-GRAFT IMPLANTATION FOR POSTPANCREATICODUODENECTOMY HEMORRHAGE IN A PATIENT WITH A RECONSTRUCTED GASTRIC TUBE" TOMOHIRO KOMADA, MD, ET AL. RADIOLOGY CASE REPORTS. 2020 DEC; 15(12): 2710¿2713. PUBLISHED ONLINE 2020 OCT 22. IN PATIENTS WITH A RECONSTRUCTED GASTRIC TUBE, THE RIGHT GASTROEPIPLOIC ARTERY IS A VERY IMPORTANT FEEDING ARTERY OF THE TUBE, WHICH MUST BE PRESERVED WHEN PERFORMING A PANCREATICODUODENECTOMY. A (B)(6) MAN WITH A RECONSTRUCTED GASTRIC TUBE UNDERWENT PANCREATICODUODENECTOMY FOR DISTAL BILE DUCT CARCINOMA. ON POSTOPERATIVE DAY 8, HE HAD AN ARTERIAL HEMORRHAGE FROM A DRAIN, APPARENTLY FROM A LIGATION OF THE ANTERIOR SUPERIOR DUODENAL ARTERY. HE, THEREFORE, UNDERWENT STENT-GRAFT (6 MM × 2.5 CM, VIABAHN; W. L. GORE, NEWARK, DE) PLACEMENT IN THE GASTRODUODENAL ARTERY ON POSTOPERATIVE DAY 16. ANGIOGRAPHY AFTER IMPLANTATION DID NOT DELINEATE THE PROXIMAL PORTION OF THE STENT-GRAFT, AND THE POSSIBILITY OF DISSECTION OF THE PROXIMAL VESSEL WAS CONSIDERED. A 6 MM × 5 CM STENT-GRAFT (VIABAHN) WAS THEN PLACED IN FRONT OF THE FIRST STENT-GRAFT IN THE STENT, AND FURTHER LIGHT CRIMPING WAS PERFORMED WITH A BALLOON CATHETER (SABER; CORDIS, CARDINAL HEALTH, DUBLIN, OH). TWO DAYS AFTER STENT-GRAFT IMPLANTATION, THE STENT-GRAFTS WERE TEMPORARILY OCCLUDED, AND THE GASTRIC TUBE WAS NECROTIZING. HOWEVER, THROMBOLYTIC THERAPY ALLOWED THE STENT-GRAFTS TO REOPEN AND PREVENTED GASTRIC TUBE NECROSIS. THE ISCHEMIC CHANGES IN THE GASTRIC TUBE IMPROVED ON ENDOSCOPY 6 DAYS AFTER THE THROMBECTOMY (FIG. 3D). HEPARIN WAS CHANGED TO ANTIPLATELET MEDICATIONS (ASPIRIN AND CLOPIDOGREL SULFATE), AND THE PATIENT WAS DISCHARGED 53 DAYS AFTER SURGERY. THE CT AT 3 MONTHS AFTER STENT-GRAFT IMPLANTATION SHOWED THAT THE STENT-GRAFTS WERE OCCLUDED, BUT THE CONTRAST EFFECT OF THE GASTRIC TUBE WAS GOOD. THE PATIENT DID NOT HAVE ANY SYMPTOMS. WE BELIEVE OUR CASE OF STENT-GRAFT IMPLANTATION IN THE GASTRODUODENAL ARTERY IS THE FIRST OF THIS KIND TO SUCCESSFULLY PREVENT LETHAL NECROSIS OF THE GASTRIC TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343342 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other