CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS
Report
- Report Number
- 2017233-2025-06432
- Event Type
- Injury
- Date Received
- July 22, 2025
- Date of Event
- June 1, 2025
- Report Date
- July 30, 2025
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ARTICLE CITATION: LU S, KAN Y, HAN J, ET AL. MID-TERM RESULTS OF ENDOVASCULAR REPAIR FOR TYPE B AORTIC DISSECTION: A DEVICE-SPECIFIC COMPARATIVE ANALYSIS. ANN VASC SURG. 2025. DOI: 10.1016/J.AVSG.2025.06.002. PUBLISHED JUN-2025. A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. A4: PATIENT WEIGHT IS NOT AVAILABLE. B3: DATE OF EVENT IS UNKNOWN, THEREFORE, 1-JUN-2025. REFLECTS THE FIRST DAY OF THE MONTH THAT LITERATURE WAS AVAILABLE ONLINE. D6: IMPLANT DATE IS NOT AVAILABLE. H3: ENGINEERING EVALUATION COULD NOT BE PERFORMED AS THE INFORMATION IS NOT AVAILABLE. 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.
ADD B5 WITH ADDITIONAL DESCRIPTION OF EVENT. ADDITIONAL INVESTIGATION SUMMARY: A UNIQUE DEVICE IDENTIFICATION NUMBER WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING DATE AND/OR PRODUCTION DETAILS CANNOT BE DETERMINED. NEITHER CLINICAL IMAGES ENABLING ASSESSMENT OF PRODUCT PERFORMANCE NOR THE PRODUCT ITSELF WERE RETURNED FOR EVALUATION, THE INVESTIGATION COULD NOT BE PERFORMED. THIS COMPLAINT WAS INITIATED BASED ON INFORMATION RECEIVED AND HANDLED PER LITERATURE REVIEWS PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE FOLLOWING INFORMATION WAS NOT REPORTED TO GORE: UNIQUE DEVICE IDENTIFICATION, CLINICAL IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE, OR PRODUCT. THE AVAILABLE PATIENT INFORMATION DID NOT ADD RELEVANT INFORMATION TO FURTHER THE DEVICE FUNCTIONALITY INVESTIGATION. THE INFORMATION PROVIDED TO GORE CANNOT BE CONNECTED TO A SPECIFIC DEVICE; THEREFORE, THIS INVESTIGATION IS COMPLETE. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE AND/OR PRODUCTION DETAILS CANNOT BE DETERMINED. THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING: POTENTIAL ADVERSE EVENTS, COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO: ENDOLEAK, AORTIC EXPANSION (E.G., ANEURYSM, FALSE LUMEN, LANDING ZONE, LESION), DISSECTION, REOPERATION, SURGICAL CONVERSION.
THE FOLLOWING INFORMATION WAS RECEIVED THROUGH LITERATURE: "MID-TERM RESULTS OF ENDOVASCULAR REPAIR FOR TYPE B AORTIC DISSECTION: A DEVICE-SPECIFIC COMPARATIVE ANALYSIS" IN ANN VASC SURG 2025. THE OBJECTIVE OF THIS STUDY WAS TO COMPARE THE EFFICACY OF CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG) AND THE VALIANT CAPTIVIA SYSTEM STENT GRAFT (NON-GORE) IN THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) FOR TYPE B AORTIC DISSECTION FROM 2016 TO 2022. THE STUDY INCLUDED 617 PATIENTS [CTAG GROUP HAD 372 PATIENTS, MEAN AGE 56.8 YEARS OLD, 308 MALES]. IN THE CTAG GROUP, MID-TERM OUTCOME DURING FOLLOW-UP (MEDIAN FOLLOW-UP WAS 25.6 MONTHS): 19 CASES OF READMISSION WERE DOCUMENTED, INDICATIONS FOR READMISSION INCLUDED FALSE LUMEN ANEURYSMAL EXPANSION [N=4], RTAD [N=1], ¿SEVERE¿ ENDOLEAK [N=3], DISTAL STENT GRAFT-INDUCED NEW ENTRY [DSINE] [N=7], ABDOMINAL AORTIC ANEURYSM [N=1], PERIPHERAL ARTERIAL STENOSIS [N=2] AND ORGAN MALPERFUSION [N=1]. AS FOR REINTERVENTION STRATEGIES, 3 READMITTED PATIENTS UNDERWENT ASCENDING AORTA AND ARCH REPLACEMENT AND 9 UNDERWENT SECONDARY TEVAR. THE REMAINING READMITTED PATIENTS RECEIVED CONSERVATIVE TREATMENT AND FOLLOW-UP MONITORING.
SHORT-TERM OUTCOME DURING HOSPITALIZATION (9.3 DAYS): RETROGRADE TYPE A DISSECTION [RTAD] [N: 1].
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 767736 | CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W. L. GORE & ASSOCIATES, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male | Required Intervention |