GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
Report
- Report Number
- 2017233-2023-04421
- Event Type
- Injury
- Date Received
- November 22, 2023
- Date of Event
- August 11, 2023
- Report Date
- February 20, 2024
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE ABLUMINAL SURFACE WAS GENERALLY DEVOID OF TISSUE, EXCEPT FOR MINIMAL, SCATTERED TAN AND RED/BROWN TISSUE. THE VISIBLE PORTIONS OF THE LUMEN WERE GENERALLY DEVOID OF TISSUE, EXCEPT FOR SCANT AMOUNTS OF TAN AND RED/BROWN TISSUE. THE VISIBLE PORTIONS OF THE LUMEN WERE PATENT; HOWEVER, THE PATENCY OF THE DEVICE COULD NOT BE DETERMINED BASED ON THE ANALYSIS OR IMAGES PROVIDED. NO MATERIAL DISRUPTIONS WERE PRESENT. THE PRESENCE OF BACTERIA WOULD BE EXPECTED BECAUSE OF THE DEVICES DIRECT CONTACT WITH THE ESOPHAGUS. NO INFORMATION WAS PROVIDED TO CONFIRM THE PRESENCE OR ABSENCE OF THE REPORTED INFECTION AND NO DETERMINATION CAN BE MADE FROM THE PROVIDED INFORMATION. BASED ON THE EXPLANT SCIENTIST¿S REVIEW OF THE THIRD PARTY LAB'S REPORT, NO ADDITIONAL ANALYSIS IS REQUESTED. ADDITIONAL INFORMATION, INCLUDING WHEN THE PATIENT FIRST PRESENTED WITH AN INFECTION AND WHETHER THE INFECTION PRE-DATED THE IMPLANTATION WAS REQUESTED FROM THE PHYSICIAN BUT WAS NOT PROVIDED. ACCORDING TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO STENT GRAFT INFECTION.
H3: DEVICE RETURNED TO THIRD PARTY EXPLANT CENTER FOR EVALUATION. 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.
IT WAS REPORTED THAT ON (B)(6) 2023, A PATIENT PRESENTING WITH AN AORTOESOPOGEAL FISTULA WAS TREATED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2023, THE DEVICE WAS EXPLANTED DUE TO INFECTION.
IT WAS REPORTED THAT ON (B)(6) 2023, A PATIENT PRESENTING WITH AN AORTOESOPOGEAL FISTULA WAS TREATED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2023, THE DEVICE WAS EXPLANTED DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1756941 | GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W. L. GORE & ASSOCIATES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |