BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® MOLDING & OCCLUSION BALLOON CATHETER

    MDR report key: 18297564 · Received December 8, 2023

    Report

    Report Number
    3007284313-2023-02933
    Event Type
    Injury
    Date Received
    December 8, 2023
    Date of Event
    November 16, 2023
    Report Date
    July 12, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MJN
    UDI-DI
    00733132639489
    PMA / PMN Number
    K172567
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2A: PRODUCT CODE CORRECTION WAS MADE: FROM DQY TO MJN.

    Additional Manufacturer Narrative · 0

    H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE WAS DISCARDED AT FACILITY. RETURN NOT POSSIBLE. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® MOLDING AND OCCLUSION BALLOON CATHETER INSTRUCTIONS FOR USE, ADVERSE EVENTS WHICH MAY REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE VESSEL WALL, INCLUDING SPASM, DISSECTION, PERFORATION OR RUPTURE. 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

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6), 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS FOR ABDOMINAL AORTIC ANEURYSM AND A RIGHT COMMON ILIAC ARTERY ANEURYSM. AN AORTIC EXTENDER ENDOPROSTHESIS WAS DEPLOYED TO REINFORCE PROXIMAL SEALING. REPORTEDLY, GORE® MOLDING & OCCLUSION BALLOON WAS USED FOR THE PROXIMAL TOUCH-UP. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2023, CONTRAST-ENHANCED COMPUTED TOMOGRAPHY SCAN WAS PERFORMED. RETROGRADE AORTIC DISSECTION WAS CONFIRMED NEAR THE PROXIMAL END OF THE AORTIC EXTENDER ENDOPROSTHESIS. ALTHOUGH THE EXTENT OF THE DISSECTION COULD NOT BE CONFIRMED, IT WAS SUGGESTED THAT IT MAY HAVE EXTENDED TO THE DESCENDING AORTA. THE PHYSICIAN STATED AS FOLLOWS: THIS MIGHT BE BECAUSE PROXIMAL TOUCH-UP WAS PERFORMED MORE THAN USUAL FOR SEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769536 GORE® MOLDING & OCCLUSION BALLOON CATHETER CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN W. L. GORE & ASSOCIATES, INC. 00733132639489
    2345002 GORE® MOLDING & OCCLUSION BALLOON CATHETER CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN W. L. GORE & ASSOCIATES, INC. 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention