BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 19644083 · Received July 1, 2024

    Report

    Report Number
    2017233-2024-05069
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 10, 2024
    Report Date
    August 22, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 DESCRIBE EVENT OR PROBLEM WAS UPDATED.

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE CASE NUMBER. H6 EVALUATION CODES INVESTIGATION FINDINGS C19 REFERS TO THE PRODUCT HISTORY REVIEW: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE DELIVERY CATHETER WAS RETURNED AND AN ENGINEERING INVESTIGATION WILL BE CONDUCTED. 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

    ENGINEERING EVALUATION: RETURNED WAS THE DELIVERY SYSTEM WITHOUT A STENT PRESENT. THE PRIMARY REPORTED COMPLAINT OF DIFFICULTY DEFLATING THE VBX DEVICE BALLOON AFTER DEPLOYMENT COULD NOT BE INDEPENDENTLY CONFIRMED. THE VBX DEVICE DELIVERY SYSTEM AS RETURNED FOR EVALUATION WAS ABLE TO BE SUCCESSFULLY INFLATED AND DEFLATED WITH NO DIFFICULTY ENCOUNTERED. CLINICAL FACTORS (E.G. PATIENT ANATOMY, PROCEDURAL CONDITIONS) POTENTIALLY IMPACTING DEFLATION CANNOT BE REPLICATED IN THE LABORATORY SETTING. THE ROOT CAUSE OF THE DIFFICULTY DEFLATING THE VBX DEVICE BALLOON AFTER DEPLOYMENT AS REPORTED COULD NOT BE ESTABLISHED WITH THE INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A KISSING STENT PROCEDURE IN THE COMMON ILIAC ARTERY WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX-DEVICES). IT WAS STATED THAT AS INFLATION MEDIUM NORMAL SALINE WAS USED INSTEAD OF THE RECOMMENDED STANDARD INFLATION MEDIUM OF A 50/50 MIXTURE OF CONTRAST MEDIUM AND NORMAL SALINE. IT WAS STATED THAT AFTER PLACEMENT OF THE VBX-DEVICE, DURING DEFLATION OF THE BALLOON CATHETER, THE BALLOON COULD NOT BE DEFLATED FIRST. AFTER MULTIPLE ATTEMPTS AND RE-DILATATION IT WAS POSSIBLE, AND NO FURTHER ACTIONS MUST BE TAKEN. THE RESULT WAS AS DESIRED AND THERE WAS NO REPORT OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A KISSING STENT PROCEDURE IN THE COMMON ILIAC ARTERY WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX-DEVICE). IT WAS STATED THAT AFTER PLACEMENT OF THE VBX-DEVICE, DURING DEFLATION OF THE BALLOON CATHETER, THE BALLOON COULD NOT BE UNBLOCKED FIRST. AFTER MULTIPLE ATTEMPTS AND RE-DILATATION IT WAS POSSIBLE, AND NO FURTHER ACTIONS MUST BE TAKEN. THIS WAS NOT PERFORMED WITH CONTRAST MEDIUM, BUT WITH NACL. THE RESULT WAS AS DESIRED AND THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256469 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other