BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 21300950 · Received February 4, 2025

    Report

    Report Number
    2017233-2025-05793
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    October 1, 2020
    Report Date
    March 11, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    UDI-DI
    00733132641581
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS B3, B5 AND B7 WERE UPDATED BASED ON THE ADDITIONAL INFORMATION REPORTED. DEVICE CATALOG NUMBER, SERIAL NUMBER, UDI, EXPIRATION DATE, AND IMPLANT DATE WERE ADDED. G2: COMPANY REPRESENTATIVE WAS ADDED. H6: CODE B14: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    KAZUKI MAEDA, ET AL. TWO CASES OF REINTERVENTION FOR DEFORMED VBX STENT GRAFTS IMPLANTED IN THE ABDOMINAL AORTA. THE JOURNAL OF JAPANESE COLLEGE OF ANGIOLOGY. VOL. 64, SUPPL. PAGE S1733. A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. H6: CODE D1001: THE LITERATURE STATES THE DEFORMATION OF THE DEVICE WAS RELATED TO EXTERNAL PRESSURE APPLIED TO THE ABDOMEN AS A CONSEQUENCE OF PATIENT LIFESTYLE/HABITS. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODES IS CONSISTENT WITH PATIENT-RELATED FACTORS AS REPORTED. HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. 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

    EVENT DESCRIPTION HAS BEEN UPDATED AS FOLLOWS: ON (B)(6) 2020, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR COMMON ILIAC ARTERY OCCLUSION. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBXS) WERE IMPLANTED FROM THE ABDOMINAL AORTA INTO BILATERAL COMMON ILIAC ARTERIES BY KISSING BALLOON TECHNIQUE (KBT). THE DEVICES USED WERE: - RIGHT SIDE: BXA073901J ((B)(6)) - LEFT SIDE: BXA075901J ((B)(6)) (MOST PROXIMAL), BXA077901J ((B)(6)), BXA077901J ((B)(6)) BOTH GBXA077901JS WERE IMPLANTED IN THE COMMON ILIAC ARTERY (CIA) BUT NOT IN THE AORTA. IN (B)(6) 2020, THE PATIENT PRESENTED WITH CLAUDICATION SYMPTOMS IN THE RIGHT LOWER LIMB. CTA CONFIRMED THE COMPRESSION OF THE BILATERAL VBXS IN THE AORTA. BOTH CIA VBXS REMAINED PATENT, BUT THROMBOTIC OCCLUSION WAS OBSERVED IN THE AORTA-RIGHT CIA AT THE COMPRESSED SITE, NECESSITATING RE-INTERVENTION. APPROXIMATELY TWO WEEKS PRIOR, THE PATIENT HAD UNDERGONE HEMORRHOID SURGERY AND REPORTED SYMPTOMS ONE WEEK POSTOPERATIVELY. IT WAS CONFIRMED THAT THE PATIENT HAD BEEN FORCED INTO A FORWARD-BENDING POSITION DURING LUMBAR ANESTHESIA, WHICH WAS SUSPECTED TO BE THE CAUSE OF THE VBX COMPRESSION. ON (B)(6) 2020, AN ADDITIONAL PROCEDURE WAS PERFORMED. TWO VBXS WERE IMPLANTED PROXIMAL TO THE INITIAL DEVICES WITH KBT. THE DEVICES USED WERE: - RIGHT SIDE: BXA083901J ((B)(6)). - LEFT SIDE: BXA083901J ((B)(6)). IN AUGUST 2021, SURGICAL THROMBECTOMY AND BALLOONING OF THE VBXS WERE PERFORMED TO ADDRESS RECURRENT VBX COMPRESSION AT THE PROXIMAL SITE AND THROMBOTIC OCCLUSION. IT WAS UNKNOWN WHICH DEVICE(S) WERE AFFECTED BY THE THROMBOTIC OCCLUSION. (THE EVENT IN AUGUST 2021 WAS SEPARATELY CAPTURED UNDER MEDWATCH REPORT NUMBER: 2017233-2025-05909, 2017233-2025-05910, 2017233-2025-05911, AND 2017233-2025-05912.) ON (B)(6) 2021, ANOTHER REINTERVENTION WAS PERFORMED FOR RECURRENT VBX COMPRESSION. KBT WAS PERFORMED USING A 10MM X 4CM BALLOON. SUBSEQUENTLY, A BARE-METAL STENTS 10MM X 4CM WERE PLACED APPROXIMATELY 1CM PROXIMAL TO THE VBXS USING KBT, AND THE PROCEDURE WAS COMPLETED. DURING THIS STAGE OF THE SECOND RE-TREATMENT, IT WAS FOUND THAT THE PATIENT WAS ENGAGED IN CONSTRUCTION WORK, CARRYING STEEL PLATES AGAINST THE ABDOMEN. (THE EVENT ON (B)(6) 2021 WAS SEPARATELY CAPTURED UNDER MEDWATCH REPORT NUMBER: 2017233-2025-05795 AND 2017233-2025-05796.).

    Description of Event or Problem · 0

    THE FOLLOWING LITERATURE WAS REVIEWED: KAZUKI MAEDA, ET AL. TWO CASES OF REINTERVENTION FOR DEFORMED VBX STENT GRAFTS IMPLANTED IN THE ABDOMINAL AORTA. THE JOURNAL OF JAPANESE COLLEGE OF ANGIOLOGY. VOL. 64, SUPPL. PAGE S1733. CASE 1 THE PATIENT WAS A 71-YEAR-OLD MAN. ENDOVASCULAR TREATMENT WAS PERFORMED FOR LEFT COMMON ILIAC ARTERY OCCLUSION. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX DEVICES) WERE IMPLANTED FROM THE ABDOMINAL AORTA INTO BILATERAL COMMON ILIAC ARTERIES BY KISSING BALLOON TECHNIQUE (KBT). SEVEN MONTHS AFTER THE PROCEDURE, A CT SCAN SHOWED THE PROXIMAL END OF THE VBX DEVICES WERE COMPRESSED AND THE RIGHT SIDE VBX DEVICE WAS OCCLUDED. THROMBECTOMY OF THE RIGHT SIDE VBX DEVICE WAS PERFORMED, AND TWO ADDITIONAL VBX DEVICES WERE IMPLANTED BY KBT ON THE PROXIMAL SIDE OF THE BILATERAL PREVIOUS VBX DEVICES. ELEVEN MONTHS LATER, A CT SCAN SHOWED THAT THE PROXIMAL END OF THE VBX DEVICES WERE COMPRESSED. THEY WERE NOT OCCLUDED BUT THERE WAS A POSSIBILITY OF FUTURE OCCLUSION, SO A SECOND REINTERVENTION WAS PERFORMED. BARE-METAL STENTS WERE IMPLANTED TO RELINE VBX DEVICES WHICH WERE PLACED IN THE AORTA. THE PATIENT WAS THIN AS HIS BMI AT 16. ACCORDING TO THE INTERVIEW OF HIS MEDICAL HISTORY, THE PATIENT CARRIED STEEL PLATES OR OTHER OBJECTS AGAINST HIS STOMACH AT A CONSTRUCTION SITE, WHICH WAS THOUGHT TO HAVE EXERTED EXTERNAL PRESSURE ON THE VBX DEVICES. DISCUSSION: THE PATIENT WAS THIN AND THE DEFORMATION OF THE DEVICE WAS SHOWN AT THE PART OF ABDOMEN WHERE EXTERNAL PRESSURE WAS APPLIED. THE VBX DEFORMITIES WERE CAUSED BY LIFESTYLE HABITS, ETC. ONCE IT OCCURRED, THERE IS A GOOD POSSIBILITY THAT THE SAME DEFORMITY IS REPEATED EVEN AFTER REINTERVENTION. THEREFORE, CLOSE ATTENTION SHOULD BE PAID TO PATIENT¿S BODY SHAPE AND LIFESTYLE WHEN USING VBX DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245696 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC. 00733132641581

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention