GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS
Report
- Report Number
- 2017233-2025-06574
- Event Type
- Injury
- Date Received
- September 8, 2025
- Date of Event
- July 7, 2025
- Report Date
- December 11, 2025
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
HUISTRA EWM, TIELLIU IFJ, MAZURI A, KATER GM, ZEEBREGTS CJ. PERCUTANEOUS TRANSTHORACIC COIL EMBOLIZATION OF A GUTTER-RELATED TYPE IA ENDOLEAK AFTER CHIMNEY THORACIC ENDOVASCULAR AORTIC REPAIR, VASC SURG CASES, INNOV TECH. 2025;11(5):101906. A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. B3: THE DATE EVENT IS UNKNOWN, THEREFORE, DATE OF EVENT WAS CHOSEN AS WHEN THE LITERATURE WAS PUBLISHED ONLINE, HERE JULY 7, 2025. B13: FURTHER INFORMATION GATHERING ATTEMPTS STARTED WITH THE AUTHOR. THE DEVICE IS NOT ACCESSIBLE TO GORE. HENCE NO PRODUCT EVALUATION IS POSSIBLE. H3: REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. 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.
UPDATED G3. UPDATED B2: UPDATED TO 'YES': REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES). UPDATED G4: 510(K)/PMA NUMBER WAS CORRECTED. P210032 IS NO LONGER APPLICABLE.
G3 UPDATED. B5 - DESCRIBE EVENT OR PROBLEM UPDATED: THE GORE BRAND NAME WAS UPDATED, BECAUSE CORRECTION OF THE PRODUCT NAME IS REQUIRED. H6, MEDICAL DEVICE PROBLEM CODE: A2304 ADDED. TYPE OF INVESTIGATION: CODE B11 ADDED. INVESTIGATION FINDINGS: CODE C19 ADDED. CODE C21 IS NO LONGER APPLICABLE. INVESTIGATION CONCLUSIONS: CODE D15 AND D1103 ADDED. CODE D16 IS NO LONGER APPLICABLE. INVESTIGATION RESULTS & CONCLUSION: NO SERIAL NUMBER PROVIDED BY AUTHOR. THEREFORE, THE REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE ESTABLISHED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED. AS THE DEVICE REMAINED IMPLANTED, NO FURTHER INVESTIGATION OF THE DEVICE CAN BE CONDUCTED. NEITHER CLINICAL IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE, NOR THE DEVICE WAS RETURNED FOR EVALUATION. FURTHER, THE INFORMATION PROVIDED IN THAT LITERATURE ARTICLE INDICATES AN OFF-LABEL USE TO THE USED GORE® DEVICES. THE AVAILABLE INFORMATION REPORTED IN THE COMPLAINT DOES NOT REASONABLY SUGGEST A POTENTIAL MALFUNCTION OR PRODUCT PACKAGING AND/OR LABELING ISSUE HAS OCCURRED. THE CAUSE TO THE REPORTED ENDOLEAK TYPE 1A CANNOT BE ESTABLISHED. FURTHER, THE INFORMATION PROVIDED IN THAT LITERATURE ARTICLE INDICATES AN OFF-LABEL USE TO THE USED GORE® TAG® CONFORMABLE THORACIC STENT GRAFT (CTAG DEVICE). PER H6, FOR THE INVESTIGATION CONCLUSION (CODE D1103 WAS CHOSEN), THE FOLLOWING IFU STATEMENT IS APPLICABLE: THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT IS DESIGNED TO TREAT AORTIC NECK DIAMETERS NO SMALLER THAN 16 MM AND NO LARGER THAN 42 MM. THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT IS DESIGNED TO TREAT PROXIMAL AND DISTAL AORTIC NECK LENGTHS NO LESS THAN 20 MM FOR ISOLATED LESIONS. ADDITIONAL PROXIMAL AORTIC NECK LENGTH MAY BE GAINED BY COVERING THE LEFT SUBCLAVIAN ARTERY (WITH OR WITHOUT DISCRETIONARY TRANSPOSITION) WHEN NECESSARY TO OPTIMIZE DEVICE FIXATION AND MAXIMIZE AORTIC NECK LENGTH. DISTAL AORTIC NECK LENGTH OF AT LEAST 20 MM PROXIMAL TO THE CELIAC AXIS IS REQUIRED. WHEN TREATING TYPE B DISSECTIONS, A MINIMUM OF 20 MM OF LANDING ZONE LENGTH IS REQUIRED PROXIMAL TO THE PRIMARY ENTRY TEAR WITH THE VERY PROXIMAL EXTENT BEING NON-DISSECTED. TOTAL TREATMENT LENGTH SHOULD INCLUDE A MINIMUM OF 10 CM DISTAL TO THE PRIMARY ENTRY TEAR WHERE THE DISTAL END OF THE DEVICE TERMINATES IN A STRAIGHT SEGMENT OF THE AORTA. THESE SIZING MEASUREMENTS ARE CRITICAL TO THE PERFORMANCE OF THE ENDOVASCULAR REPAIR. THE FINAL TREATMENT DECISION IS AT THE DISCRETION OF THE PHYSICIAN AND PATIENT.
THE FOLLOWING LITERATURE ARTICLE WAS REVIEWED: HUISTRA EWM, TIELLIU IFJ, MAZURI A, KATER GM, ZEEBREGTS CJ. PERCUTANEOUS TRANSTHORACIC COIL EMBOLIZATION OF A GUTTER-RELATED TYPE IA ENDOLEAK AFTER CHIMNEY THORACIC ENDOVASCULAR AORTIC REPAIR, VASC SURG CASES, INNOV TECH. 2025;11(5):101906. HTTPS://DOI.ORG/10.1016/J.JVSCIT.2025.101906. A CASE REPORT OF A 82-YEAR-OLD PATIENT WITH HISTORY OF HYPERTENSION AND ACUTE TYPE B DISSECTION. THE PATIENT WAS TREATED WITH THORACIC ENDOVASCULAR AORTIC REPAIR [TEVAR] USING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS [40X200 MM] AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS [11X59MM] AS A CHIMNEY STENT INTO THE LEFT SUBCLAVIAN ARTERY [LSA] AND THERE WAS APPROXIMATELY 15.5MM OVERLAP OF THE STENT AND CHIMNEY STENT. IMPLANT DATE IS UNKNOWN. ON DAY 5 POST-OP, A CT ANGIOGRAPHY [CTA] REVEALED A SMALL ENDOLEAK. AT THE ONE MONTH FOLLOW UP, CTA REVEALED A SIGNIFICANT TYPE 1A ENDOLEAK, PRESUMED TO ORIGINATE FROM THE GUTTER ALONG WITH A 4-MM INCREASE IN THE AORTIC DIAMETER. A COIL EMBOLIZATION OF THE ENDOLEAK WAS PERFORMED AND DURING THE PROCEDURE, THE INITIAL DIGITAL SUBTRACTION ANGIOGRAPHY REVEALED NO EVIDENCE OF AN ENDOLEAK, HOWEVER, CONTRAST INJECTION IN TO THE FALSE LUMEN SHOWED A TYPE 1A ENDOLEAK. COIL EMBOLIZATION WAS PERFORMED SUCCESSFULLY AND FOLLOW UP AT 2 MONTHS CONFIRMED COMPLETE RESOLUTION OF THE ENDOLEAK.
THE FOLLOWING LITERATURE ARTICLE WAS REVIEWED: HUISTRA EWM, TIELLIU IFJ, MAZURI A, KATER GM, ZEEBREGTS CJ. PERCUTANEOUS TRANSTHORACIC COIL EMBOLIZATION OF A GUTTER-RELATED TYPE IA ENDOLEAK AFTER CHIMNEY THORACIC ENDOVASCULAR AORTIC REPAIR, VASC SURG CASES, INNOV TECH. 2025;11(5):101906. HTTPS://DOI.ORG/10.1016/J.JVSCIT.2025.101906. A CASE REPORT OF AN 82-YEAR-OLD PATIENT WITH HISTORY OF HYPERTENSION AND ACUTE TYPE B DISSECTION. THE PATIENT WAS TREATED WITH THORACIC ENDOVASCULAR AORTIC REPAIR [TEVAR] USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM [40X200 MM] AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS [11X59MM] AS A CHIMNEY STENT INTO THE LEFT SUBCLAVIAN ARTERY [LSA] AND THERE WAS APPROXIMATELY 15.5MM OVERLAP OF THE STENT AND CHIMNEY STENT. IMPLANT DATE IS UNKNOWN. ON DAY 5 POST-OP, A CT ANGIOGRAPHY [CTA] REVEALED A SMALL ENDOLEAK. AT THE ONE MONTH FOLLOW UP, CTA REVEALED A SIGNIFICANT TYPE 1A ENDOLEAK, PRESUMED TO ORIGINATE FROM THE GUTTER ALONG WITH A 4-MM INCREASE IN THE AORTIC DIAMETER. A COIL EMBOLIZATION OF THE ENDOLEAK WAS PERFORMED AND DURING THE PROCEDURE, THE INITIAL DIGITAL SUBTRACTION ANGIOGRAPHY REVEALED NO EVIDENCE OF AN ENDOLEAK, HOWEVER, CONTRAST INJECTION IN TO THE FALSE LUMEN SHOWED A TYPE 1A ENDOLEAK. COIL EMBOLIZATION WAS PERFORMED SUCCESSFULLY AND FOLLOW UP AT 2 MONTHS CONFIRMED COMPLETE RESOLUTION OF THE ENDOLEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2055903 | GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W. L. GORE & ASSOCIATES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Unknown | Required Intervention| O |