BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE

    MDR report key: 21797209 · Received April 8, 2025

    Report

    Report Number
    2017233-2025-06041
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    February 24, 2025
    Report Date
    July 1, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE CASE NUMBER. AS THE DEVICE REMAINS IMPLANTED, NO FURTHER INVESTIGATION OF THE DEVICE CAN BE CONDUCTED. PRODUCT HISTORY REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE SERIAL/LOT NUMBER REMAINS UNKNOWN. FURTHER DETAILS ARE REQUESTED FROM THE AUTHOR, BUT NOTHING WAS PROVIDED YET. CBAS® HEPARIN SURFACE INCORPORATES CARMEDA-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. LITERATURE ARTICLE: FERNÁNDEZ ÁLVAREZ, I., FERNÁNDEZ LORENZO, J., VIDAL REY, J. AND ENCISA DE SÁ, J.M. (2025). INFECTED PARAVISCERAL ANEURYSM REPAIR WITH PARALLEL STENT GRAFTS. VASC SPE´C INT. 41, PP.1. DOI:10.5758/VSI.240093. 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 HAVE NOT 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 · 0

    NEITHER CLINICAL IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE, NOR THE DEVICE WAS RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED TO GORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE ESTABLISHED. IN THE INSTRUCTION FOR USE FOR THE GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE THE FOLLOWING IS STATED: ADVERSE EVENTS. POSSIBLE ADVERSE EVENTS AND COMPLICATIONS THAT MAY OCCUR WITH THE USE OF ANY GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE OR IN ANY ENDOVASCULAR PROCEDURE AND REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: OCCLUSION (THROMBOSIS AND/OR STENOSIS) OF ENDOPROSTHESIS OR VESSEL.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS REVIEWED: FERNÁNDEZ ÁLVAREZ, I., FERNÁNDEZ LORENZO, J., VIDAL REY, J. AND ENCISA DE SÁ, J.M. (2025). INFECTED PARAVISCERAL ANEURYSM REPAIR WITH PARALLEL STENT GRAFTS. VASC SPE´C INT. 41, PP.1. DOI:10.5758/VSI.240093. THIS IS A TWO CASE REPORTS OF PATIENTS WITH INFECTED AORTIC ANEURYSMS. PATIENT 1 IS CAPTURED IN THE CURRENT CASE (B)(4), PATIENT 2 IS CAPTURED IN (B)(4). A 75-YEAR-OLD MALE WITH HISTORY OF CELLULITIS OF THE LEFT ARM ADMITTED FOR DIFFUSE ABDOMINAL PAIN. CTA REVEALED NEWLY DEVELOPED SACCULAR ANEURYSM AT THE LEVEL OF THE CELIAC TRUNK [CT] AND ALVEOLAR LESION SUGGESTIVE OF PNEUMONIA. HIS LABS REVEALED LEUKOCYTOSIS AND ELEVATED CRP AND THESE FINDINGS SUGGESTED INFECTED ANEURYSM WITH PROBABLY CONTAINED RUPTURE. ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED AND THE CT WAS OCCLUDED AT ITS ORIGIN. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT [34X100MM] AND A GORE® VIABAHN® ENDOPROSTHESIS [8X150MM] WAS PLACED IN THE SUPERIOR MESENTERIC ARTERY [SMA] AND REINFORCED WITH REINFORCED INTERNALLY WITH AN 8×100 MM ABSOLUTE PRO SELF-EXPANDING STENT. COMPLETION ANGIOGRAPHY CONFIRMED PATENCY OF THE RENAL ARTERIES, SMA, AND CT (VIA COLLATERAL CIRCULATION) BUT DETECTED A TYPE II ENDOLEAK THROUGH THORACIC BRANCHES (PROBABLY THE INTERCOSTAL ARTERIES) WITH FILLING OF THE ANEURYSMAL SAC. THE ANEURYSM SAC WAS EMBOLIZED WITH AZUR COILS (TERUMO MEDICAL CORP.) FINAL ANGIOGRAPHY CONFIRMED ANEURYSM EXCLUSION, NO VISIBLE ENDOLEAK, AND PRESERVED VISCERAL ARTERY PATENCY. INTRAOPERATIVE BLOOD SAMPLES TAKEN DIRECTLY FROM THE ANEURYSM TESTED POSITIVE FOR METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS [MSSA]. POSTOPERATIVELY, THE PATIENT DEVELOPED ABDOMINAL PAIN AND WAS TAKEN TO SURGERY FOR ACUTE CHOLECYSTITIS AND RIGHT COLON ISCHEMIA REQUIRING CHOLECYSTECTOMY AND RIGHT COLECTOMY WITH TERMINAL ILEOSTOMY. POSTOPERATIVE CTA SHOWED DISTAL SMA THROMBOSIS. THE PATIENT RECOVERED AND AT 35 MONTHS, THE PATIENT REMAINED ASYMPTOMATIC AND ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740585 GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention GORE STENT GRAFT THORACIC CONFORMABLE.