BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 15221995 · Received August 12, 2022

    Report

    Report Number
    2017233-2022-03211
    Event Type
    Injury
    Date Received
    August 12, 2022
    Date of Event
    July 27, 2022
    Report Date
    November 3, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    SECTION H6 UPDATED TO REFLECT COMPLETION OF INVESTIGATION. PATIENT AND EVENT INFORMATION WERE REQUESTED, BUT AUTHOR DECLINED TO PROVIDE ANY DETAILS. AS A RESULT, FURTHER INVESTIGATION WAS NOT POSSIBLE.

    Description of Event or Problem · 0

    THE FOLLOWING LITERATURE ARTICLE WAS REVIEWED: 'ENDOVASCULAR TREATMENT OF POPLITEAL ARTERY ANEURYSMS HAS COMPARABLE LONG-TERM OUTCOMES TO OPEN REPAIR WITH SHORTER LENGTHS OF STAY' CORRESPONDING AUTHORS; NOOR G. SHAH, MD, RAE S. ROKOSH, MD, KARAN GARG, MD, BRENT SAFRAN, MD, CARON B. ROCKMAN, MD, THOMAS S. MALDONADO, MD, MIKEL SADEK, MD, PATRICK LAMPARELLO, MD, GLENN R. JACOBOWITZ, MD, MICHAEL E. BARFIELD, MD, FRANK VEITH, MD, AND NEAL S. CAYNE, MD, NEW YORK, NY. AN ABSTRACT ARTICLE; USING A RETROSPECTIVE REVIEW OF THE MEDICAL RECORDS, WE IDENTIFIED ALL PATIENTS WITH A DIAGNOSIS OF ¿ANEURYSM OF ARTERY OF LOWER EXTREMITY¿ (INTERNATIONAL CLASSIFICATION OF DISEASES CODE 442.3) AT OUR SINGLE TERTIARY CARE CENTER FROM 1998 TO 2017. OVERALL, 97% OF THE PATIENTS WERE MEN, WITH A MEAN AGE AT DIAGNOSIS OF 72.3 YEARS (RANGE, 56-91 YEARS). ALL ERS WERE PERFORMED WITH THE VIABAHN ENDOPROSTHESIS (W.L. GORE AND ASSOCIATES, INC, FLAGSTAFF, ARIZ). OR WAS PERFORMED VIA A MEDIAL OR POSTERIOR APPROACH USING EITHER AN AUTOLOGOUS GREAT SAPHENOUS VEIN (GSV) GRAFT OR A PROSTHETIC CONDUIT. IN THE ABSENCE OF AN APPROPRIATE VENOUS CONDUIT, A PROSTHETIC GRAFT WAS USED (DISTAFLO [BARD PERIPHERAL VASCULAR, INC, TEMPE, ARIZ]; PROPATEN [W.L. GORE AND ASSOCIATES, INC]; OR GORE-TEX [W.L. GORE AND ASSOCIATES, INC]). THE MEAN FOLLOW-UP WAS 76 MONTHS (RANGE, 0-180 MONTHS). NO PATIENT HAD REQUIRED IMMEDIATE (<1 DAY) OR EARLY (<1 MONTH) REINTERVENTION. THREE PATIENTS HAD REQUIRED REINTERVENTION AT <1 YEAR AND SEVEN HAD REQUIRED REINTERVENTION AT >1 YEAR, INCLUDING BOTH OR AND ER. ONE PATIENT HAD REQUIRED CONVERSION TO OR BECAUSE THE GRAFT WAS NOTED TO HAVE SIGNIFICANT KINKING, OCCLUDING OUTFLOW. NO PATIENT IN THE ER COHORT HAD EXPERIENCED STENT-GRAFT FRACTURES OR LIMB LOSS DURING FOLLOW-UP. EIGHT PATIENTS HAD DIED (20%) DURING FOLLOW-UP, ALL OF CAUSES UNRELATED TO THE PAA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2854763 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male