BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® MOLDING & OCCLUSION BALLOON CATHETER

    MDR report key: 15937133 · Received December 7, 2022

    Report

    Report Number
    3007284313-2022-02252
    Event Type
    Injury
    Date Received
    December 7, 2022
    Date of Event
    December 5, 2022
    Report Date
    December 15, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    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

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE IS GOING TO BE CONDUCTED. THE INVESTIGATION IS IN PROCESS. FURTHER INFORMATION WILL BE PROVIDED. THE BALLOON WAS DISCARDED AT THE FACILITY AND IS NOT AVAILABLE FOR ANALYSIS. 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

    H6: CODE C19: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE BALLOON WAS DISCARDED AT THE FACILITY AND IS NOT AVAILABLE FOR ANALYSIS. ACCORDING TO THE GORE® MOLDING & OCCLUSION BALLOON CATHETER INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS WHICH MAY REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO TRAUMA TO THE VESSEL WALL, INCLUDING SPASM, DISSECTION, PERFORATION OR RUPTURE. IFU CAUTION: BALLOON INFLATION SHOULD ONLY BE PERFORMED WHILE CLOSELY MONITORING UNDER FLUOROSCOPY. DO NOT INFLATE THE BALLOON TO A DIAMETER LARGER THAN THE VESSEL IT IS BEING INFLATED WITHIN. DO NOT EXCEED 37 MM BALLOON DIAMETER, BALLOON RUPTURE MAY OCCUR. DO NOT EXCEED 48 CC INFLATION VOLUME AT 37 MM CONSTRAINED BALLOON DIAMETER. BALLOON OVER-INFLATION MAY RESULT IN VESSEL DAMAGE OR RUPTURE. ADDITIONALLY, THE IFU STATES: DO NOT INFLATE THE BALLOON IN AREAS OF SIGNIFICANT CALCIFIED PLAQUE. BALLOON RUPTURE AND / OR VESSEL DAMAGE MAY OCCUR. INCORRECT USAGE OF THE BALLOON CATHETER MAY REQUIRE ADDITIONAL PROSTHESIS PLACEMENT OR SURGICAL INTERVENTION. TO AVOID VESSEL TRAUMA, DO NOT OVER-INFLATE THE BALLOON IN RELATION TO THE DIAMETER OF THE VESSEL OR OTHER DEVICES. THE GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS REPORTED SEPARATELY ON DECEMBER 7, 2022: MANUFACTURER REPORT NUMBER 3013164176-2022-01565.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESES. WHEN THE TOUCH UP BALLOONING WAS PERFORMED BY A GORE® MOLDING & OCCLUSION BALLOON (MOB) TO A CONTRALATERAL LEG ENDOPROSTHESIS IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY, THE DISTAL END OF THE DEVICE WAS DISSECTED DUE TO THE EXCESSIVE BALLOONING, AND THE BLOOD FLOW OF THE RIGHT INTERNAL ILIAC ARTERY WAS LOST DUE TO THE FALSE LUMEN. A BARE METAL STENT WAS IMPLANTED IN THE RIGHT INTERNAL ILIAC ARTERY, AND THE BLOOD FLOW WAS RECOVERED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT THE BALLOONING WAS NOT PERFORMED MUCH STRONGLY, THERE WAS A CALCIFICATION IN THE RIGHT COMMON ILIAC ARTERY TO THE RIGHT INTERNAL ILIAC ARTERY AND THIS CALCIFICATION MIGHT BE INVOLVED WITH THE DISSECTION. REPORTEDLY, THE BALLOON WAS EXPANDED WITH THE STATUS THAT THE MARKER OF THE BALLOON WAS LOCATED WITHIN THE STENT GRAFT, HOWEVER IT SEEMED THE BALLOON DEFORMED DUE TO THE EXCESSIVE EXPANSION AND THE DEFORMED BALLOON MIGHT HAVE BEEN LOCATED OUTSIDE OF THE STENT GRAFT.

    Description of Event or Problem · 0

    REPORTEDLY, THE BALLOON WAS EXPANDED WITH THE STATUS THAT THE MARKER OF THE BALLOON WAS LOCATED WITHIN THE STENT GRAFT, HOWEVER, DUE TO THE EXCESSIVE EXPANSION, THE PART OF THE BALLOON MIGHT HAVE BEEN LOCATED OUTSIDE OF THE STENT GRAFT. REPORTEDLY, THE EXACT INFLATION VOLUME IS UNKNOWN. THE VESSEL¿S SIZE AT THE AREA WHERE THE BALLOON WAS USED WAS 12.9 X 12.5 MM. NO RESISTANCE WAS REPORTED DURING ADVANCEMENT OR RETRACTION OF THE BALLOON CATHETER. THERE WERE TWICE INFLATION/DEFLATION CYCLES USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2259814 GORE® MOLDING & OCCLUSION BALLOON CATHETER SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. MOB37 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| O| H