GORE® EXCLUDER® AAA ENDOPROSTHESIS
Report
- Report Number
- 3007284313-2024-03462
- Event Type
- Malfunction
- Date Received
- September 2, 2024
- Date of Event
- May 17, 2019
- Report Date
- December 6, 2024
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- UDI-DI
- 00733132618477
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B3, DATE OF EVENT: UPDATED. B5, DESCRIBE EVENT OR PROBLEM: UPDATED DESCRIPTION. H6, MEDICAL DEVICE PROBLEM CODE: UPDATED.
EMDR SECTION H6: CODES HAVE BEEN ADDED/UPDATED TO REFLECT THE EXTENT OF THE INVESTIGATION PERFORMED. B1, PRODUCT PROBLEM (E.G., DEFECTS/MALFUNCTIONS): UPDATED SELECTION. B2, OUTCOMES ATTRIBUTED TO ADVERSE EVENT: UPDATED SELECTION. B5, DESCRIBE EVENT OR PROBLEM: PROVIDED ADDITIONAL INFORMATION. H6, HEALTH EFFECT - CLINICAL CODE: REPLACED CODE E050102 WITH E2403. H6, HEALTH EFFECT - IMPACT CODE: REPLACED CODE F2301 WITH F26. H6, MEDICAL DEVICE PROBLEM CODE: REPLACED CODE A051204 WITH A010402. THIS COMPLAINT WAS INITIATED BASED ON INFORMATION RECEIVED FROM THE FIELD. THE DEVICE REMAINS IMPLANTED AND COULD THEREFORE NOT BE EVALUATED. ADDITIONAL INFORMATION RECEIVED FROM THE STUDY SITE INDICATED THAT THE REPORTED MEGA AORTA SYNDROME WITH AN ANEURYSM INCREASE OF 9 CM CONCERNED THE THORACIC AORTA. IT THEREFORE APPEARS THAT THE REPORTED INTERVENTION TO TREAT THIS THORACIC CONDITION WITH A NON-GORE DEVICE WAS UNRELATED TO THE ABDOMINAL ANEURYSM TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES ON (B)(6) 2014. REPORTEDLY, NO MEDICAL IMAGES OR ADDITIONAL MEASUREMENTS WERE AVAILABLE. GORE WAS THEREFORE UNABLE TO INDEPENDENTLY CONFIRM THE REPORTED DEVICE MIGRATION IN THIS PATIENT. HOWEVER, IT WAS REPORTED THAT THE ABDOMINAL ANEURYSM MEASURED 49 MM ON TWO FOLLOW-UP IMAGING OCCASIONS. IT THEREFORE APPEARS THE ANEURYSM REMAINED STABLE DESPITE THE DEVICE MIGRATION. NO FURTHER INFORMATION WAS PROVIDED TO GORE FOR THIS PATIENT. THE REPORTED MIGRATION IS A KNOWN ADVERSE EVENT. BASED ON THE AVAILABLE INFORMATION AND THE SUBSEQUENT INVESTIGATION, WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS INCIDENT AND ASSIGN A ROOT CAUSE. 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: ENDOPROSTHESIS OR DELIVERY SYSTEM: COMPONENT MIGRATION.
H3, CODE "OTHER": THE DEVICE REMAINS IMPLANTED. THEREFORE, AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. H6, INVESTIGATION FINDINGS, CODE C19 - THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. 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.
ON (B)(6) 2014 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM OF 51 MM IN DIAMETER AND WAS THEREFORE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ADDITIONAL INFORMATION RECEIVED STATED THAT BETWEEN MARCH 21, 2014 AND MAY 17, 2019, FOLLOW-UP CTA IMAGES SHOWED THE DEVICE HAD MIGRATED DISTALLY RELATIVE TO THE LEFT RENAL ARTERY FROM INITIALLY 3 TO 30 MM. REPORTEDLY, AN ENDOLEAK DID NOT DEVELOP. ON MAY 31, 2019, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THE ABDOMINAL ANEURYSM HAD DECREASED TO 49 MM IN DIAMETER. ON (B)(6) 2020, THE PATIENT WAS REPORTEDLY DIAGNOSED WITH MEGA AORTA SYNDROME AND AN AORTIC GROWTH OF MORE THAN 9 CM WAS FOUND. ON THE SAME DAY, THE PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR WITH A CUSTOMIZED, NON-GORE THORACIC DEVICE. REPORTEDLY, THIS WAS UNRELATED TO THE PREVIOUS ABDOMINAL AORTIC ANEURYSM REPAIR. ON JUNE 26, 2020, FOLLOW-UP CTA REVEALED THAT THE ABDOMINAL ANEURYSM STILL MEASURED 49 MM IN DIAMETER.
REPORTEDLY, AN ENDOLEAK DID NOT DEVELOP AND NO OTHER MEASUREMENTS OR IMAGING RESULTS WERE AVAILABLE.
ON (B)(6) 2014 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM OF 51 MM IN DIAMETER AND WAS THEREFORE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2019, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THE ANEURYSM HAD DECREASED TO 49 MM IN DIAMETER. ON (B)(6) 2020, THE PATIENT WAS REPORTEDLY DIAGNOSED WITH MEGA AORTA SYNDROME AND AN AORTIC GROWTH OF MORE THAN 9 CM WAS FOUND. ON THE SAME DAY, THE PATIENT WAS IMPLANTED WITH AN ADDITIONAL AORTIC ENDOPROSTHESIS. ON (B)(6) 2020, FOLLOW-UP CTA REVEALED THAT THE ANEURYSM MEASURED 49 MM IN DIAMETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1107993 | GORE® EXCLUDER® AAA ENDOPROSTHESIS | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W. L. GORE & ASSOCIATES, INC. | 00733132618477 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | Required Intervention| H |