GORE® EXCLUDER® AAA ENDOPROSTHESIS
Report
- Report Number
- 3007284313-2025-03775
- Event Type
- Death
- Date Received
- February 18, 2025
- Date of Event
- January 22, 2025
- Report Date
- March 28, 2025
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 505
Narratives
UPDATED SECTION G3/G4, AND H10. THE PATIENTS REFERENCED IN THIS EVENT FILE ARE ENROLLED IN THE COLLABORATIVE LONG-TERM EVAR ASSESSMENT AND FOLLOW-UP (LEAF) POST-MARKET SURVEILLANCE PROJECT THROUGH (B)(6). ALL INFORMATION CONTAINED IN THIS EVENT FILE WAS RECEIVED FROM THE (B)(6) DATA BASE. (B)(6) IS NOT MANAGED, MAINTAINED OR SUPERVISED BY GORE OR ANY REPRESENTATIVE OF GORE. THE INITIAL INFORMATION OBTAINED FROM (B)(6) IS THE ONLY INFORMATION BEING PROVIDED. FURTHER INVESTIGATION IS NOT POSSIBLE AS IDENTIFIABLE DATA AS TO SITE(S), PHYSICIAN(S), PATIENT(S), DEVICE(S) AND/OR SPECIFIC DATE(S) ARE NOT BEING PROVIDED. THE COMPLAINT FILE WILL REFLECT LEAF AS THE STUDY NAME. IT IS LIKELY THESE INDIVIDUAL EVENTS HAVE BEEN PREVIOUSLY CAPTURED AND REPORTED BY GORE, BUT DUE TO THE NATURE OF THIS STUDY AND ANONYMITY OF THE PATIENT AND DEVICE DATA, GORE IS UNABLE TO CONFIRM THIS. FOR THIS REASON, GORE WILL SUBMIT ONE REPORT FOR MULTIPLE REPORTABLE EVENTS WHERE THE INDIVIDUALLY IDENTIFIABLE INFORMATION OF THE DEVICE IS NOT AVAILABLE AND NO ADDITIONAL INFORMATION WILL BE PROVIDED BECAUSE WE CANNOT OBTAIN ENOUGH INFORMATION ABOUT EACH IDENTIFIED PATIENT AND/OR DEVICE MENTIONED IN ORDER TO PROVIDE A COMPLETE REPORT FOR EACH REPORTABLE EVENT. THE REGISTRIES ARE LIKELY TO CONTAIN DEVICES FOR THE GORE® EXCLUDER® AAA ENDOPROSTHESIS, THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, AND POTENTIALLY THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE DATA GIVEN DID NOT DIFFERENTIATE WHICH OF THE SPECIFIC DEVICES CONTRIBUTED TO THE SERIOUS INJURIES. THEREFORE, WE REPORT ALL EVENTS FOR ALL DEVICES ON THE SAME REPORT. DEVICE BRAND NAME: GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. PMA NUMBER: P200030. DEVICE BRAND NAME: GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. PMA NUMBER: P020004.
THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN THE LONG-TERM EVAR ASSESSMENT AND FOLLOW-UP (LEAF) RETROSPECTIVE STUDY PROVIDED AN INITIAL UPDATE REGARDING THE PROCEDURAL OUTCOMES OF CURRENTLY ENROLLED PARTICIPANTS FOLLOWING IMPLANT OF GORE® EXCLUDER® AAA ENDOPROSTHESIS. ALL INFORMATION CONTAINED IN THIS EVENT FILE WAS RECEIVED FROM KAISER PERMANENTE EVAR REGISTRY SITES AND LINKED TO MEDICARE FEE FOR SERVICE DATA. THE INITIAL INFORMATION OBTAINED FROM KAISER PERMANENTE IS THE ONLY INFORMATION BEING PROVIDED. FURTHER INVESTIGATION IS NOT POSSIBLE AS IDENTIFIABLE DATA AS TO SITE(S), PHYSICIAN(S), PATIENT(S), DEVICE(S) AND/OR SPECIFIC DATE(S) ARE NOT BEING PROVIDED. A.2. AGE AT THE TIME OF EVENT: THE MEAN AGE FOR THE SUBJECTS IN THIS DATASET IS 76 YEARS. THEREFORE, 76 YEARS HAS BEEN USED AS THE ESTIMATED PATIENT AGE. A.3. GENDER: THE MAJORITY OF SUBJECTS IN THIS DATASET ARE MALE. THEREFORE, MALE HAS BEEN USED AS THE ESTIMATED PATIENT GENDER. A.4. PATIENT WEIGHT: THE AVERAGE WEIGHT OF THE PATIENTS WAS NOT GIVEN IN THE REPORTS. B.3. DATE OF EVENT: AS THE INDEX PROCEDURE DATE(S) AND DATE OF EVENT(S) REMAIN UNAVAILABLE, THE DATE OF EVENT HAS BEEN ESTIMATED AS THE DATE GORE AWARE OF THE INITIAL DATA EXPORT: 22-JAN-2025. D.4. DEVICE INFORMATION: THE DEVICE LOT/SERIAL NUMBER(S) REMAINS UNAVAILABLE. THEREFORE, DEVICE INFORMATION REMAINS UNKNOWN. D.10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: THIS INFORMATION REMAINS UNAVAILABLE TO GORE. H.4. DEVICE MANUFACTURE DATE: AS THE DEVICE LOT/SERIAL NUMBERS ARE UNAVAILABLE, THE DEVICE MANUFACTURE DATES REMAINS UNKNOWN. H.6. TYPE OF INVESTIGATION: CODE B22 - AS THE DEVICE LOT/SERIAL NUMBERS ARE UNAVAILABLE, NO DEVICE HISTORY RECORD REVIEW WAS ABLE TO BE COMPLETED. IT SHOULD BE NOTED THAT, PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, DEATH. 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.
THE LONG-TERM EVAR ASSESSMENT AND FOLLOW-UP (LEAF) RETROSPECTIVE STUDY PROVIDED AN INITIAL UPDATE REGARDING THE PROCEDURAL OUTCOMES OF CURRENTLY ENROLLED PARTICIPANTS FOLLOWING IMPLANT OF GORE® EXCLUDER® AAA ENDOPROSTHESIS. THIS EVENT COVERS THE DATA REPORTED FROM THE KAISER PERMANENTE EVAR REGISTRY SITES AND LINKED TO MEDICARE FEE FOR SERVICE DATA. IN THE INITIAL REPORT, 1987 SUBJECTS WERE IMPLANTED WITH THE GORE EXCLUDER C3, (B)(6)2014 TO (B)(6) 2022. IN THAT PERIOD, THE FOLLOWING NEW ADVERSE EVENTS WERE REPORTED: 21 DEATHS DURING HOSPITALIZATION (AVERAGE HOSPITAL STAY IS 2 DAYS), 25 RE-TREATMENT DURING HOSPITALIZATION. A KAPLAN-MEIER GRAPH WAS INCLUDED IN THE REPORT SHOWING FREEDOM FROM ANEURYSM RELATED MORTALITY. AT THE 5 YEAR FOLLOW-UP THE KAPLAN MEIER ESTIMATE WAS THAT APPROXIMATELY 1.5% OF SUBJECTS HAD ANEURYSM-RELATED MORTALITY. POST-OP COMPLICATIONS -GRAFT RELATED (REVISION) (2). RETREATMENT DURING HOSPITALIZATIONS INDICATIONS INCLUDES: ABDOMINAL COMPARTMENT SYNDROME (2) ISCHEMIC BOWEL (1) DISSECTION (2) ENDOLEAK (3) OCCLUSION (11) RUPTURE-2 STENOSIS-2. RE-INTERVENTIONS AT 1 YEAR FOLLOW-UP, THE FOLLOWING WAS OBSERVED: DISSECTION (3), ENDOLEAK (31), FEMORAL-FEMORAL BYPASS GRAFT (1), GRAFT INFECTION (5), MIGRATION (4), OCCLUSION-17, PSEDO ANEURYSM-2, RUPTURE-2, SAC GROWTH-1, STENOSIS-8, TREATMENT OF INTERNAL ILIAC-2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2571065 | 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 | Male | Death| O |