BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 14953729 · Received July 8, 2022

    Report

    Report Number
    2017233-2022-03102
    Event Type
    Injury
    Date Received
    July 8, 2022
    Date of Event
    January 11, 2020
    Report Date
    August 2, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN UNKNOWN LOT/SERIAL NUMBER AND NO DEVICE RETURN, AN INVESTIGATION COULD NOT BE PERFORMED AND CONFIRMED THE CAUSE OF THE REPORTED ISSUE FOR THIS EVENT. CBAS® 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.

    Additional Manufacturer Narrative · 0

    CITATION: SHER-LYN THAM, YUXIN GUO, MARIA CUI-YING PANG, JACK KIAN CHNG, SURGICAL MANAGEMENT OF AXILLARY ARTERY ANEURYSMS WITH ENDOVASCULAR STENTING VERSUS OPEN REPAIR: A REPORT OF TWO CASES AND LITERATURE REVIEW, ANNALS OF VASCULAR SURGERY, VOLUME 58, 2019, PAGES 385.E11-385.E16, ISSN 0890-5096, HTTPS://DOI.ORG/10.1016/J.AVSG.2018.11.010.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS RECEIVED THROUGH LITERATURE ¿SURGICAL MANAGEMENT OF AXILLARY ARTERY ANEURYSMS WITH ENDOVASCULAR STENTING VERSUS OPEN REPAIR: A REPORT OF TWO CASES AND LITERATURE REVIEW¿ PUBLISHED BY CATHETER CARDIOVASC INTERV. 2020; 95:1163¿1168. THE STUDY WAS TO EVALUATE AXILLARY ARTERY ANEURYSMS NECESSITATE REPAIR AGAINST CONVENTIONAL OPEN REPAIR, WITH INCREASING ENDOVASCULAR INTERVENTIONS FOR THESE UNCOMMON LESIONS. THE RESULTS STATE IN CASE 2, A 65-YEAR-OLD GENTLEMAN PRESENTED WITH A ONE-DAY HISTORY OF INCREASING PAIN OVER HIS LEFT ARM, WITH NO OTHER NEUROLOGICAL DEFICIT. ON (B)(6) 2017, PLACEMENT OF A 6 × 50 MM VIABAHN (W. L. GORE & ASSOCIATES, FLAGSTAFF, AZ) STENT GRAFT ACROSS THE ANEURYSM WAS PERFORMED (FIG. 5). ON POSTOPERATIVE DAY 1, THE PATIENT DEVELOPED A TENDER, EDEMATOUS LEFT UPPER LIMB WITH AN ULTRASOUND ARTERIAL DOPPLER SCAN REVEALING A NEW LEFT BRACHIAL PSEUDOANEURYSM MEASURING 16 × 7 MM WITH A SHORT WIDE NECK OF 2 MM AT THE SITE OF PREVIOUS ARTERIAL PUNCTURE. ATTEMPTS OF ULTRASOUND-GUIDED COMPRESSION AND BANDAGING FAILED TO RESOLVE THE PSEUDOANEURYSM. THE PATIENT THEN UNDERWENT A SECOND OPERATION FOR OPEN REPAIR AND HEMOSTASIS OF THE LEFT BRACHIAL ARTERY PSEUDOANEURYSM. AFTER THE SECOND REPAIR, THE PATIENT HAD NO FURTHER COMPLAINTS OF HIS LEFT UPPER LIMB AND WAS DISCHARGED ON POSTOPERATIVE DAY 7.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS RECEIVED THROUGH LITERATURE ¿SURGICAL MANAGEMENT OF AXILLARY ARTERY ANEURYSMS WITH ENDOVASCULAR STENTING VERSUS OPEN REPAIR: A REPORT OF TWO CASES AND LITERATURE REVIEW¿ PUBLISHED BY ANNALS OF VASCULAR SURGERY, VOLUME 58, 2019, PAGES 385.E11-385.E16. THE STUDY WAS TO EVALUATE AXILLARY ARTERY ANEURYSMS NECESSITATE REPAIR AGAINST CONVENTIONAL OPEN REPAIR, WITH INCREASING ENDOVASCULAR INTERVENTIONS FOR THESE UNCOMMON LESIONS. THE RESULTS STATE IN CASE 2, A 65-YEAR-OLD GENTLEMAN PRESENTED WITH A ONE-DAY HISTORY OF INCREASING PAIN OVER HIS LEFT ARM, WITH NO OTHER NEUROLOGICAL DEFICIT. ON (B)(6) 2017, PLACEMENT OF A 6 × 50 MM VIABAHN (W. L. GORE & ASSOCIATES, FLAGSTAFF, AZ) STENT GRAFT ACROSS THE ANEURYSM WAS PERFORMED (FIG. 5). ON POSTOPERATIVE DAY 1, THE PATIENT DEVELOPED A TENDER, EDEMATOUS LEFT UPPER LIMB WITH AN ULTRASOUND ARTERIAL DOPPLER SCAN REVEALING A NEW LEFT BRACHIAL PSEUDOANEURYSM MEASURING 16 × 7 MM WITH A SHORT WIDE NECK OF 2 MM AT THE SITE OF PREVIOUS ARTERIAL PUNCTURE. ATTEMPTS OF ULTRASOUND-GUIDED COMPRESSION AND BANDAGING FAILED TO RESOLVE THE PSEUDOANEURYSM. THE PATIENT THEN UNDERWENT A SECOND OPERATION FOR OPEN REPAIR AND HEMOSTASIS OF THE LEFT BRACHIAL ARTERY PSEUDOANEURYSM. AFTER THE SECOND REPAIR, THE PATIENT HAD NO FURTHER COMPLAINTS OF HIS LEFT UPPER LIMB AND WAS DISCHARGED ON POSTOPERATIVE DAY 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086221 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