BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 13995742 · Received April 4, 2022

    Report

    Report Number
    3013164176-2022-01344
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    March 9, 2022
    Report Date
    April 19, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618712
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED THE FOLLOWING COMORBIDITIES AND MEDICATIONS WERE PROVIDED COMORBIDITIES - DYSLIPIDEMIA, HYPERTENSION, DIABETES, HYPERCALCEMIA, SMOKER. MEDICATIONS - NORCO, ATIVAN, NEURONTIN, VITAMIN D, PRINIVIL, GLUCOPHAGE, ZOCOR, TYLENOL AS GORE WAS UNABLE TO DETERMINE WHICH DEVICE (S) CAUSED OR CONTRIBUTED TO THE EVENT IF ANY; ADDITIONAL DEVICE(S) IMPLANTED RELATED TO THIS EVENT INCLUDE TH FOLLOWING GORE® EXCLUDER® AAA ENDOPROSTHESIS, STENT GRAFT CONTRALATERAL LEG (PLC1410000), LOT/SERIAL - (B)(4), UDI: (B)(4). GORE® EXCLUDER® AAA ENDOPROSTHESIS, STENT GRAFT ILIAC EXTENDER (PLL1614070), LOT/SERIAL: (B)(4), UDI: (B)(4). (B)(4).

    Additional Manufacturer Narrative · 0

    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. H6: CODE 213, NO DEVICE PROBLEM FOUND ¿ A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE 22, KNOWN INHERENT RISK OF DEVICE - ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS IFU, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO: OCCLUSION OF DEVICE OR NATIVE VESSEL. ALSO ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ALL LENGTHS AND DIAMETERS OF THE DEVICES NECESSARY TO COMPLETE THE PROCEDURE SHOULD BE AVAILABLE TO THE PHYSICIAN, ESPECIALLY WHEN PRE-OPERATIVE CASE PLANNING MEASUREMENTS (TREATMENT DIAMETERS / LENGTHS) ARE NOT CERTAIN. THIS APPROACH ALLOWS FOR GREATER INTRAOPERATIVE FLEXIBILITY TO ACHIEVE OPTIMAL PROCEDURAL OUTCOMES. ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE BUT ARE NOT LIMITED TO: PATIENT¿S ANATOMICAL SUITABILITY FOR ENDOVASCULAR REPAIR, AND FREEDOM FROM SIGNIFICANT FEMORAL / ILIAC ARTERY OCCLUSIVE DISEASE THAT WOULD IMPEDE INFLOW OR OUTFLOW OF STENT-GRAFTS. SUCCESSFUL PATIENT AND DEVICE SELECTION IS DEPENDENT ON KNOWLEDGE OF RADIOGRAPHIC IMAGE INTERPRETATION, DEVICE SELECTION AND SIZING. RECOMMENDED ENDOPROSTHESIS OVERSIZING RELATIVE TO THE VESSEL IS APPROXIMATELY 7-25% FOR CONTRALATERAL LEG AND ILIAC EXTENDER COMPONENTS.

    Description of Event or Problem · 0

    ON (B)(6), 2022 THE PATIENT UNDERWENT EVAR FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH THE FOLLOWING GORE ENDOPROSTHESES: CXT261412 (LOT/SN:(B)(4)) GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS - TRUNK IPSILATERAL LEG; PLC121200 (LOT/SN: (B)(4)) GORE® EXCLUDER® AAA ENDOPROSTHESIS - CONTRALATERAL LEG; PLC141000 (LOT/SN: (B)(4)) GORE® EXCLUDER® AAA ENDOPROSTHESIS - CONTRALATERAL LEG; PLL161407 (LOT/SN: (B)(4)) GORE® EXCLUDER® AAA ENDOPROSTHESIS - ILIAC EXTENDER. AT THE ONE MONTH FOLLOW UP VISIT CT IMAGING REVEALED STENOSIS IN THE RIGHT LIMB. THIS WAS REPORTEDLY THE RESULT OF THE PREVIOUSLY IMPLANTED STENTS COMPETING FOR SPACE WITHIN THE SMALL VESSEL AREA (1000-E:-OTHER). AS REPORTED, THE PATIENT WAS ASYMPTOMATIC. ON (B)(6), 2022 THE PATIENT UNDERWENT A PLANNED REINTERVENTION IN WHICH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES WERE IMPLANTED IN THE RIGHT LIMB. THE LEFT SIDE WAS ACCESSED, BUT ONLY TO PLACE A BALLOON IN ORDER TO COUNTERACT THE STENT INFLATION (KISSING BALLOON TECHNIQUE). AS REPORTED, THE PATIENT TOLERATED THE PROCEDURE. INFORMATION REGARDING WHICH ENDOPROSTHESES WENT DOWN THE RIGHT LEG AND WHICH WENT DOWN THE LEFT LEG WAS REQUESTED BUT WAS NOT PROVIDED AND REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95250 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. PLC121200 00733132618712

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention