BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 15937141 · Received December 7, 2022

    Report

    Report Number
    3013164176-2022-01565
    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
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE REMAINS IMPLANTED 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

    H.6. CODE C19: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H.6. CODE B20: THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO VASCULAR TRAUMA (I.E., DISSECTION, RUPTURE, PERFORATION, TEAR, ETC.)AND OCCLUSION OF DEVICE OR NATIVE VESSEL. ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE BUT ARE NOT LIMITED TO PATIENT¿S ANATOMICAL SUITABILITY FOR ENDOVASCULAR REPAIR. ALSO, KEY ANATOMIC ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE SIGNIFICANT THROMBUS AND / OR CALCIUM AT THE ARTERIAL IMPLANTATION SITES, SPECIFICALLY THE PROXIMAL AORTIC NECK AND DISTAL ILIAC ARTERY INTERFACE. IRREGULAR CALCIUM AND / OR PLAQUE MAY COMPROMISE THE FIXATION AND SEALING OF THE IMPLANTATION SITES. THE GORE® MOLDING & OCCLUSION BALLOON CATHETER WAS REPORTED SEPARATELY ON DECEMBER 7, 2022: MANUFACTURER REPORT NUMBER 3007284313-2022-02252.

    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 DISSECTION OCCURRED IN THE RIGHT COMMON ILIAC ARTERY AT THE DISTAL END OF THE CONTRALATERAL LEG ENDOPROSTHESIS. THE PHYSICIAN STATED THAT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2260811 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other| R| H