BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 19238931 · Received May 3, 2024

    Report

    Report Number
    3007284313-2024-03207
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    June 16, 2023
    Report Date
    July 23, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. A2: THE MEAN AGE AMONG THE PATIENTS WAS REPORTED TO 78.9 YEARS. A3: MAJORITY OF THE PATIENTS IN THE STUDY WAS MALE. B3: THE EXACT DATE OF EVENT IS UNKNOWN, THEREFORE, THE DATE OF WHICH LITERATURE ARTICLE WAS PUBLISHED ONLINE WAS USED AS DATE OF EVENT. H3: OTHER CODE ¿ THE MEDICAL DEVICES ARE NOT RETURNED FOR INVESTIGATION, THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE SERIAL/LOT NUMBER REMAINS UNKNOWN. GORE REACHED OUT TO THE AUTHOR OF THE LITERATURE ARTICLE FOR DEVICE IDENTIFICATION LINKED WITH THE REPORTED OUTCOME. LITERATURE CITATION: BONVINI, S., SPADONI, N., FRIGATTI, P., ANTONELLO, M., IRSARA, S., VERALDI, G. F., MILITE, D., GALEAZZI, E., LEPIDI, S., PERKMANN, R., TASSELLI, S., ET AL. (2023) ¿EARLY OUTCOMES OF THE CONFORMABLE ENDOGRAFT IN SEVERE NECK ANGULATION FROM THE TRIVENETO CONFORMABLE REGISTRY,¿ JOURNAL OF VASCULAR SURGERY, 78(4), PP. 954-962.E2. DOI: 10.1016/J.JVS.2023.06.006. 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

    GORE HAS MADE MULTIPLE ATTEMPTS TO REQUESTED DEVICE IDENTIFICATION AND OTHER PATIENT RELATED DATA FROM THE CORRESPONDING AUTHOR. THE AUTHOR HAS NOT PROVIDED ANY ADDITIONAL INFORMATION. REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. THE DEVICE REMAINS IMPLANTED IN 3 OF THE PATIENTS AND WAS EXPLANTED IN 1 PATIENT (OF WHICH ALSO NOT RETURNED TO GORE). THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. BASED ON THE INCIDENT DESCRIPTION AND THE SUBSEQUENT INVESTIGATION, NO FURTHER INFORMATION WAS PROVIDED TO GORE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS INCIDENT AND ASSIGN A ROOT CAUSE. PER THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO: ANEURYSM ENLARGEMENT, CLAUDICATION (E.G., BUTTOCK, LOWER LIMB), COMPONENT MIGRATION, ENDOLEAK, OCCLUSION / STENOSIS OF DEVICE OR NATIVE VESSEL, SURGICAL CUT DOWN, BYPASS, OR CONVERSION. CORRECTED H6: ADDED HEALTH EFFECT - CLINICAL CODES E0509 AND E050102. CODE E0515 WAS INADVERTENTLY ENTERED AND SHOULD BE REMOVED. ADDED MEDICAL DEVICE PROBLEM CODES A010402 AND A24. ADDED COMPONENT CODE G07001. ADDED TYPE OF INVESTIGATION CODES B20, B17, AND B22. UPDATED INVESTIGATION FINDINGS CODE TO C20, CODE C21 IS NO LONGER APPLICABLE. UPDATED INVESTIGATION CONCLUSIONS CODE TO D15 AND D12, CODE D16 IS NO LONGER APPLICABLE.

    Description of Event or Problem · 0

    THE FOLLOWING LITERATURE ARTICLE WAS REVIEWED: BONVINI, S., SPADONI, N., FRIGATTI, P., ANTONELLO, M., IRSARA, S., VERALDI, G. F., MILITE, D., GALEAZZI, E., LEPIDI, S., PERKMANN, R., TASSELLI, S., ET AL. (2023) ¿EARLY OUTCOMES OF THE CONFORMABLE ENDOGRAFT IN SEVERE NECK ANGULATION FROM THE TRIVENETO CONFORMABLE REGISTRY,¿ JOURNAL OF VASCULAR SURGERY, 78(4), PP. 954-962.E2. DOI: 10.1016/J.JVS.2023.06.006. THIS IS A RETROSPECTIVE, MULTI-CENTER EVALUATION OF EARLY OUTCOMES FOR 129 PREDOMINANTLY MALE PATIENTS TREATED WITH THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS FOR ABDOMINAL AORTIC ANEURYSMS BETWEEN JANUARY 2019 AND JULY 2022. THIS STUDY SPECIFICALLY FOCUSES ON THE SEVERE NECK ANGULATION (SNA) SUBGROUP OF 56 PATIENTS WITH AN INFRARENAL ANGLE OF GREATER THAN OR EQUAL TO 60 DEGREES. THE SNA SUBGROUP HAD A MEAN AGE OF 78.9 YEARS. PRIMARY ENDPOINTS WERE TECHNICAL SUCCESS, MORTALITY, MORBIDITY, ENDOLEAKS, AND FREEDOM FROM REINTERVENTIONS AT 30 DAYS AND DURING FOLLOW-UP. THE SNA GROUP BETA ANGLE DISTRIBUTION WAS 30 PATIENTS >75 DEGREES AND 14 PATIENTS >90 DEGREES. ALL PATIENTS WITH A BETA ANGLE OF >90 (OUTSIDE THE INDICATIONS FOR USE (IFU)) WERE TREATED WITH ENDOVASCULAR ANEURYSM REPAIR (EVAR) IF CONSIDERED AT EXCESSIVE RISK FOR OPEN SURGERY. ANALYSIS REVEALED A TECHNICAL SUCCESS RATE OF 100% AND PERIOPERATIVE MAJOR COMPLICATION RATE OF 1.7%. INTRAOPERATIVE AND PERIOPERATIVE MORBIDITY AND MORTALITY RATES WERE 3.5% (ONE BUTTOCK CLAUDICATION AND ONE INGUINAL SURGICAL CUTDOWN) AND 0%, RESPECTIVELY. THE BUTTOCK CLAUDICATION SECONDARY TO HYPOGASTRIC EMBOLIZATION WAS EVIDENCED WITHIN 30 DAYS AND TREATED CONSERVATIVELY. THE INGUINAL SURGICAL CUTDOWN ON THE FIRST POSTOPERATIVE DAY WAS FOR ACUTE FEMORAL OCCLUSION. NO PERIOPERATIVE TYPE I ENDOLEAKS WERE OBSERVED. NO INTRAOPERATIVE OR PERIOPERATIVE DEATH WAS RECORDED. ONE EXTERNAL ILIAC ARTERY DISSECTION WAS DIAGNOSED AND TREATED IN THE SAME OPERATING SESSION. POSTOPERATIVE CTA WITHIN 30 DAYS SHOWED NO TYPE I/III ENDOLEAKS. THE MEDIAN FOLLOW-UP WAS 13 MONTHS. TWO REINTERVENTIONS OCCURRED (3.5%): ONE CONVERSION FOR A TYPE IA ENDOLEAK AND ONE SAC EMBOLIZATION FOR A TYPE II ENDOLEAK WITH SAC ENLARGEMENT > 5MM. ANEURYSM SAC SHRINKAGE WAS OBSERVED IN 15 PATIENTS AND ANEURYSM STABILITY IN 35 PATIENTS, RESPECTIVELY. ESTIMATED FREEDOM FROM REINTERVENTIONS AT 24 MONTHS WAS 92%.

    Description of Event or Problem · 0

    THE FOLLOWING LITERATURE ARTICLE WAS REVIEWED: BONVINI, S., SPADONI, N., FRIGATTI, P., ANTONELLO, M., IRSARA, S., VERALDI, G. F., MILITE, D., GALEAZZI, E., LEPIDI, S., PERKMANN, R., TASSELLI, S., ET AL. (2023) ¿EARLY OUTCOMES OF THE CONFORMABLE ENDOGRAFT IN SEVERE NECK ANGULATION FROM THE TRIVENETO CONFORMABLE REGISTRY,¿ JOURNAL OF VASCULAR SURGERY, 78(4), PP. 954-962.E2. DOI: 10.1016/J.JVS.2023.06.006. THIS IS A RETROSPECTIVE, MULTI-CENTER EVALUATION OF EARLY OUTCOMES FOR 129 PREDOMINANTLY MALE PATIENTS TREATED WITH THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS FOR ABDOMINAL AORTIC ANEURYSMS BETWEEN JANUARY 2019 AND JULY 2022. THIS STUDY SPECIFICALLY FOCUSES ON THE SEVERE NECK ANGULATION (SNA) SUBGROUP OF 56 PATIENTS WITH AN INFRARENAL ANGLE OF GREATER THAN OR EQUAL TO 60 DEGREES. THE SNA SUBGROUP HAD A MEAN AGE OF 78.9 YEARS. PRIMARY ENDPOINTS WERE TECHNICAL SUCCESS, MORTALITY, MORBIDITY, ENDOLEAKS, AND FREEDOM FROM REINTERVENTIONS AT 30 DAYS AND DURING FOLLOW-UP. THE SNA GROUP BETA ANGLE DISTRIBUTION WAS 30 PATIENTS >75 DEGREES AND 14 PATIENTS >90 DEGREES. ALL PATIENTS WITH A BETA ANGLE OF >90 (OUTSIDE THE INDICATIONS FOR USE (IFU)) WERE TREATED WITH ENDOVASCULAR ANEURYSM REPAIR (EVAR) IF CONSIDERED AT EXCESSIVE RISK FOR OPEN SURGERY. ANALYSIS REVEALED A TECHNICAL SUCCESS RATE OF 100% AND PERIOPERATIVE MAJOR COMPLICATION RATE OF 1.7%. INTRAOPERATIVE AND PERIOPERATIVE MORBIDITY AND MORTALITY RATES WERE 3.5% (ONE BUTTOCK CLAUDICATION AND ONE INGUINAL SURGICAL CUTDOWN) AND 0%, RESPECTIVELY. THE BUTTOCK CLAUDICATION SECONDARY TO HYPOGASTRIC EMBOLIZATION WAS EVIDENCED WITHIN 30 DAYS AND TREATED CONSERVATIVELY. THE INGUINAL SURGICAL CUTDOWN ON THE FIRST POSTOPERATIVE DAY WAS FOR ACUTE FEMORAL OCCLUSION. THE MEDIAN FOLLOW-UP WAS 13 MONTHS. TWO REINTERVENTIONS OCCURRED (3.5%): ONE SAC EMBOLIZATION FOR A TYPE II ENDOLEAK WITH SAC ENLARGEMENT > 5MM, AND ONE CONVERSION FOR A TYPE IA ENDOLEAK DUE TO AORTIC NECK ENLARGEMENT AND ENDOGRAFT CAUDAL MIGRATION IN A SEVERELY CONICAL NECK. ANEURYSM SAC SHRINKAGE WAS OBSERVED IN 15 PATIENTS AND ANEURYSM STABILITY IN 35 PATIENTS, RESPECTIVELY. ESTIMATED FREEDOM FROM REINTERVENTIONS AT 24 MONTHS WAS 92%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305161 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other