GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
Report
- Report Number
- 2017233-2025-06826
- Event Type
- Injury
- Date Received
- November 14, 2025
- Date of Event
- July 1, 2025
- Report Date
- December 9, 2025
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDED B5, G3/G4, H1/H2. CORRECTED: D1.
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 FOLLOWING PUBLICATION WAS REVIEWED BY GORE: TITLE: SINGLE-INSTITUTION EXPERIENCE WITH SHAPE MEMORY POLYMER SPONGE EMBOLIZATION AS ADJUNCT THERAPY FOR RAPID AORTIC REMODELING IN THE MULTI-MODAL MANAGEMENT OF COMPLEX PERSISTENT LARGE FALSE LUMENS FOLLOWING AORTIC DISSECTION PUBLISHED: JULY 2025. THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE ADJUNCTIVE USE OF SHAPE MEDICAL¿S IMPEDE-FX SHAPE MEMORY POLYMER (SMP) SPONGE DEVICES IN PROMOTING RAPID SAC REGRESSION AND COMPLETE FALSE LUMEN (FL) OCCLUSION IN PATIENTS WITH COMPLEX, LARGE PERSISTENT FLS AFTER AORTIC DISSECTION. A PATIENT WITH HYPERTENSION PRESENTED IN SEPTEMBER 2024 WITH AN ACUTE TYPE A AORTIC DISSECTION (TAAD) COMPLICATED BY RIGHT LOWER EXTREMITY (RLE) MALPERFUSION. SEPTEMBER 2024: THERE WAS A TOTAL ARCH REPLACEMENT (UTILIZED TERUMO THORAFLEX ANTE-FLO 32MM STENT AND TRIFURCATED GRAFT). RIGHT EXTERNAL ILIAC AND COMMON FEMORAL ARTERY DISSECTION TREATMENT (UTILIZED BOSTON SCIENTIFIC STENT). RIGHT SUPERFICIAL FEMORAL ARTERY CANNULATION SITE CLOSED WITH AN 8MM × 5CM VIABAHN STENT AFTER PERFUSION WAS RESTORED. OCTOBER 2024: THE PATIENT RE-PRESENTED WITH ABDOMINAL PAIN, EARLY SATIETY, AND POSTPRANDIAL PAIN. IMAGING REVEALED DYNAMIC COLLAPSE OF THE TRUE LUMEN (TL) IN THE PARAVISCERAL SEGMENT. RE-EXPANDED THE TL FROM ZONE 3-5 UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WORKING DOWNWARD FROM THORAFLEX STENT. 34MM × 100MM, 28MM × 150MM, 37MM × 100MM (JUNCTIONAL). DECEMBER 2024: THE PATIENT RETURNED WITH SHORTNESS OF BREATH AND HEART FAILURE. IMAGING SHOWED A LARGE TYPE IB ENDOLEAK, AORTIC SAC EXPANSION BY 3 MM AND LEFT-SIDED PLEURAL EFFUSION WITH SEROSANGUINOUS DRAINAGE. THERE WAS A REINTERVENTION FOR URGENT EMBOLIZATION OF THE FALSE LUMEN (FL). GORE ILIAC LIMB DEPLOYED INTO THE FL AS ENDOPLUGGING. 30 SHAPE MEMORY IMPEDE-FX EMBOLIZATION PLUGS WERE PLACED. AMPLATZER PLUG USED TO SEAL THE LIMB.
THE FOLLOWING PUBLICATION WAS REVIEWED BY GORE: TITLE: SINGLE-INSTITUTION EXPERIENCE WITH SHAPE MEMORY POLYMER SPONGE EMBOLIZATION AS ADJUNCT THERAPY FOR RAPID AORTIC REMODELING IN THE MULTI-MODAL MANAGEMENT OF COMPLEX PERSISTENT LARGE FALSE LUMENS FOLLOWING AORTIC DISSECTION PUBLISHED: JULY 2025. THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE ADJUNCTIVE USE OF SHAPE MEDICAL¿S IMPEDE-FX SHAPE MEMORY POLYMER (SMP) SPONGE DEVICES IN PROMOTING RAPID SAC REGRESSION AND COMPLETE FALSE LUMEN (FL) OCCLUSION IN PATIENTS WITH COMPLEX, LARGE PERSISTENT FLS AFTER AORTIC DISSECTION. A PATIENT WITH HYPERTENSION PRESENTED IN (B)(6) 2024 WITH AN ACUTE TYPE A AORTIC DISSECTION (TAAD) COMPLICATED BY RIGHT LOWER EXTREMITY (RLE) MALPERFUSION. (B)(6) 2024: THERE WAS A TOTAL ARCH REPLACEMENT (UTILIZED TERUMO THORAFLEX ANTE-FLO 32MM STENT AND TRIFURCATED GRAFT). RIGHT EXTERNAL ILIAC AND COMMON FEMORAL ARTERY DISSECTION TREATMENT (UTILIZED BOSTON SCIENTIFIC STENT). RIGHT SUPERFICIAL FEMORAL ARTERY CANNULATION SITE CLOSED WITH AN 8MM × 5CM VIABAHN STENT AFTER PERFUSION WAS RESTORED. (B)(6) 2024: THE PATIENT RE-PRESENTED WITH ABDOMINAL PAIN, EARLY SATIETY, AND POSTPRANDIAL PAIN. IMAGING REVEALED DYNAMIC COLLAPSE OF THE TRUE LUMEN (TL) IN THE PARAVISCERAL SEGMENT. RE-EXPANDED THE TL FROM ZONE 3-5 UTILIZING GORE CTAG ENDOPROSTHESES WORKING DOWNWARD FROM THORAFLEX STENT. 34MM × 100MM, 28MM × 150MM, 37MM × 100MM (JUNCTIONAL). (B)(6) 2024: THE PATIENT RETURNED WITH SHORTNESS OF BREATH AND HEART FAILURE. IMAGING SHOWED A LARGE TYPE IB ENDOLEAK, AORTIC SAC EXPANSION BY 3 MM AND LEFT-SIDED PLEURAL EFFUSION WITH SEROSANGUINOUS DRAINAGE. THERE WAS A REINTERVENTION FOR URGENT EMBOLIZATION OF THE FALSE LUMEN (FL). GORE ILIAC LIMB DEPLOYED INTO THE FL AS ENDOPLUGGING. 30 SHAPE MEMORY IMPEDE-FX EMBOLIZATION PLUGS WERE PLACED. AMPLATZER PLUG USED TO SEAL THE LIMB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2789168 | GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W. L. GORE & ASSOCIATES, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Male | Required Intervention |