MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TGM454520J

Device Problems Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135); Abdominal Distention (2601)

Event Date 12/25/2023

Event Type  Injury  

Manufacturer Narrative

H3: code "other" was selected as the medical device was discarded at facility.Return not possible.H6: a review of the manufacturing records for the device verified that the lot 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.

Event Description

The following was reported to gore: on (b)(6), 2023, the patient underwent an endovascular treatment of a distal type i endoleak from a frozen elephant trunk (fet) using non-gore device using gore® tag® conformable thoracic stent graft with active control system.Two gore® tag® conformable thoracic stent grafts with active control system (tgm454520j) were planned to implant from a descending aorta to fet.A 24fr gore® dryseal flex introducer sheath was inserted from the left side and a first gore® tag® conformable thoracic stent graft with active control system was implanted distally.Then a second gore® tag® conformable thoracic stent graft with active control system was attempted to implant proximally, but the catheter of the gore® tag® conformable thoracic stent graft with active control system was not able to be advanced due to tortuous access vessel and aorta.As a reaction to this delivery difficulty, the 24fr sheath was coming out.So, the second gore® tag® conformable thoracic stent graft with active control system was attempted to remove.However, the gore® tag® conformable thoracic stent graft with active control system was not able to be pulled into the 24fr sheath.So, the 24fr sheath was removed and the second gore® tag® conformable thoracic stent graft with active control system was removed without the sheath.When the second gore® tag® conformable thoracic stent graft with active control system was removed, the blood pressure decreased.Therefore, new 24fr gore® dryseal flex introducer sheath was inserted.The angiography revealed the left external iliac artery rupture and the bleeding from the left external iliac artery.This external iliac artery rupture was due to the gore® tag® conformable thoracic stent graft with active control system was removed without the sheath.The removed gore® tag® conformable thoracic stent graft with active control system was observed and there was a gap between the constrained stent graft part and the remaining catheter, it was like the catheter elongation occurred between the constrained stent graft part and the remaining catheter.And it seemed the catheter was not firm and it was hard to maintain the constrained stent graft.This gore® tag® conformable thoracic stent graft with active control system was abandoned to use and another gore® tag® conformable thoracic stent graft with active control system (tgm454515j) was implanted as a replacement.The gore® excluder® aaa endoprosthesis (contralateral leg) was implanted to treat the external iliac artery.A stenosis due to a damage of an intima of the external iliac artery where the distal of the contralateral leg was observed and a stent was implanted to near the canulation site to treat it.The blood flow was well.A damage of an intima of the cannulation site was treated by surgery.The damage of the intima was due to the gore® tag® conformable thoracic stent graft with active control system was removed without the sheath as well.Afterward, an abdominal compartment syndrome (acs) was observed and the blood pressure was not increased.A rupture in the aorta was suspected and an angiography was performed to the aorta.However, the rupture was not able to be confirmed.A laparotomy was performed to reduce the pressure.A transfusion etc.Were performed and the patient vital signs became stable.Then, the patient left the operating room.Reportedly, acs might have been occurred due to the left external iliac rupture because there was no rupture in the aorta.The physician stated that the left external iliac artery rupture was covered using the contralateral leg and the angiography confirmed no bleeding but the bleeding might have remained.The patient condition after the procedure is unknown.

Event Description

The following was reported to gore: on (b)(6) 2023, the patient underwent an endovascular treatment of a distal type i endoleak from a frozen elephant trunk (fet) which used a non-gore device.Two gore® tag® conformable thoracic stent grafts with active control system (tgm454520j) were planned to implant from a descending aorta to fet.A 24fr gore® dryseal flex introducer sheath was inserted from the left side and a first gore® tag® conformable thoracic stent graft with active control system was implanted distally.Then a second gore® tag® conformable thoracic stent graft with active control system was attempted to implant proximally, but the catheter of the gore® tag® conformable thoracic stent graft with active control system was not able to be advanced due to tortuous access vessel and aorta.As a reaction to this delivery difficulty, the 24fr sheath was coming out.So, the second gore® tag® conformable thoracic stent graft with active control system was attempted to remove.However, the gore® tag® conformable thoracic stent graft with active control system was not able to be pulled into the 24fr sheath.So, the second gore® tag® conformable thoracic stent graft with active control system and sheath were removed together, with the gore® tag® conformable thoracic stent graft with active control constrained stent graft not within the sheath.When the second gore® tag® conformable thoracic stent graft with active control system was removed, the blood pressure decreased.Therefore, new 24fr gore® dryseal flex introducer sheath was inserted.The angiography revealed the left external iliac artery rupture and the bleeding from the left external iliac artery.This external iliac artery rupture was due to the gore® tag® conformable thoracic stent graft with active control system was removed with not pulling back into the sheath.The removed gore® tag® conformable thoracic stent graft with active control system was observed and there was a gap between the constrained stent graft part and the remaining catheter, it was like the catheter elongation occurred between the constrained stent graft part and the remaining catheter.And it seemed the catheter was not firm and it was hard to maintain the constrained stent graft.This gore® tag® conformable thoracic stent graft with active control system was abandoned to use and another gore® tag® conformable thoracic stent graft with active control system (tgm454515j) was implanted as a replacement.The gore® excluder® aaa endoprosthesis (contralateral leg) was implanted to treat the external iliac artery.A stenosis due to a damage of an intima of the external iliac artery where the distal of the contralateral leg was observed and a stent was implanted to near the canulation site to treat it.The blood flow was well.A damage of an intima of the cannulation site was treated by surgery.The damage of the intima was due to the gore® tag® conformable thoracic stent graft with active control system was removed with not pulling back into the sheath.Afterward, an abdominal compartment syndrome (acs) was observed and the blood pressure was not increased.A rupture in the aorta was suspected and an angiography was performed to the aorta.However, the rupture was not able to be confirmed.A laparotomy was performed to reduce the pressure.A transfusion etc.Were performed and the patient vital signs became stable.Then, the patient left the operating room.Reportedly, acs might have been occurred due to the left external iliac rupture because there was no rupture in the aorta.The physician stated that the left external iliac artery rupture was covered using the contralateral leg and the angiography confirmed no bleeding but the bleeding might have remained.The patient condition after the procedure is unknown.

• Brand Name: GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: asami aizawa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18515478
• MDR Text Key: 332877231
• Report Number: 2017233-2024-04550
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TGM454520J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male