MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® TAG® THORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TAG3720

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Patient Problem/Medical Problem (2688)

Event Date 03/05/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The following information was reported to gore through the global registry for endovascular aortic treatment (great 10-11): on (b)(6) 2012, the patient underwent treatment of a complicated type b aortic dissection that had a 50 mm maximum aortic diameter and that extended from the left subclavian artery to the abdominal aorta.A goretagthoracic endoprosthesis (tag3720) was implanted distal to the left subclavian artery in zone 3 for treatment of the dissection.It was reported the patient also had a 55-60 mm diameter abdominal aortic aneurysm (aaa) at the time of implant, which was not treated during this procedure.The patient tolerated the procedure.On (b)(6) 2012, follow up imaging showed the lesion measured 47 mm.On (b)(6) 2013, follow up imaging showed the lesion measured 31 mm.On (b)(6) 2013, the patient underwent treatment whereby a non-gore device was implanted to treat aaa enlargement to 70 mm.It was reported the enlargement was caused by disease progression, which contributed to persistent perfusion of the false lumen.The patient tolerated the procedure.(previously reported under mw # 2017233-2013-00615).On (b)(6) 2014, follow up imaging showed the lesion measured 33 mm.On (b)(6) 2015, follow up imaging showed the lesion measured 80 mm.On (b)(6) 2016, a proximal type i endoleak was identified.It was reported the proximal type i endoleak resulted in persistent perfusion of the false lumen through proximal flow from the tag3720.The proximal neck was reportedly too short (length unknown) to provide proximal seal for the dissection.It was reported there was no enlargement of the thoracic aortic dissection; however, the aaa reportedly enlarged from 80 mm on (b)(6) 2015 to 98 mm on (b)(6) 2016.On (b)(6) 2016, coil embolization was performed to treat the endoleak.It was reported the false lumen began in the region of the proximal thoracic aortic neck and terminated in the aaa sac.The right renal artery was reportedly perfused by the false lumen.The embolization with coils from (b)(6) 2016 was performed through a fenestration in the dissection just below the right renal artery (in the free flow level), filling the sac of the false lumen.It was reported there was significant reduction in the blood flow to the false lumen at the end of the procedure; however, complete resolution of the endoleak reportedly could not be confirmed.There was a risk of occlusion risk of the right renal artery as the patient had chronic renal disease, so no further action was taken.It was reported the final result was satisfactory because there was almost complete exclusion of the aneurysmatic flow and preservation of flow to both renal arteries.The patient tolerated the procedure.

Manufacturer Narrative

Describe event or problem.Updated.

Event Description

On (b)(6), 2012, the patient underwent treatment of a complicated type b aortic dissection that had a 50 mm maximum aortic diameter and that extended from the left subclavian artery to the abdominal aorta.A gore® tag® thoracic endoprosthesis (tag3720) was implanted distal to the left subclavian artery in zone 3 for treatment of the dissection.It was reported the patient also had a 55-60 mm diameter abdominal aortic aneurysm (aaa) at the time of implant, which was not treated during this procedure.The patient tolerated the procedure.On (b)(6) 2012, follow up imaging showed the lesion measured 47 mm.On (b)(6) 2013, follow up imaging showed the lesion measured 31 mm.On (b)(6) 2013 the aneurysm measured 70 mm.On (b)(6) 2013, the patient underwent treatment whereby a non-gore device was implanted to treat aaa enlargement to 70 mm.It was reported the enlargement was caused by disease progression, which contributed to persistent perfusion of the false lumen.The patient tolerated the procedure.This event was previously captured under event (b)(6).On (b)(6) 2014, follow up imaging showed the lesion measured 33 mm.On (b)(6) 2014 the proximal type i endoleak was treated by means of coil embolization.On (b)(6) 2015, follow up imaging showed the lesion measured 80 mm.On (b)(6) 2016, a proximal type i endoleak was identified.It was reported the proximal type i endoleak resulted in persistent perfusion of the false lumen through proximal flow from the tag3720.The proximal neck was reportedly too short to provide proximal seal for the dissection.It was reported there was no enlargement of the thoracic aortic dissection; however, the aaa reportedly enlarged from 80 mm on (b)(6) 2015 to 98 mm on (b)(6) 2016.On (b)(6) 2016, coil embolization was performed to treat the endoleak.It was reported the false lumen began in the region of the proximal thoracic aortic neck and terminated in the aaa sac.The right renal artery was reportedly perfused by the false lumen.The embolization with coils was performed through a fenestration in the dissection just below the right renal artery (in the free flow level), filling the sac of the false lumen.It was reported there was significant reduction in the blood flow to the false lumen at the end of the procedure; however, complete resolution of the endoleak reportedly could not be confirmed.There was a reported risk of occlusion risk of the right renal artery as the patient had chronic renal disease, so no further action was taken.It was reported the final result was satisfactory because there was almost complete exclusion of the aneurysmatic flow and preservation of flow to both renal arteries.The patient tolerated the procedure.On (b)(6) 2016 a ct revealed the aneurysm measured 94 mm.

Event Description

On (b)(6) 2012, the patient underwent treatment of a complicated type b aortic dissection that had a 50 mm maximum aortic diameter and that extended from the left subclavian artery to the abdominal aorta.A gore® tag® thoracic endoprosthesis (tag3720) was implanted distal to the left subclavian artery in zone 3 for treatment of the dissection.It was reported the patient also had a 55-60 mm diameter abdominal aortic aneurysm (aaa) at the time of implant, which was not treated during this procedure.The patient tolerated the procedure.On (b)(6) 2012, follow up imaging showed the lesion measured 47 mm.On (b)(6) 2013, follow up imaging showed the lesion measured 31 mm.On (b)(6) 2013 the aneurysm measured 70mm.On (b)(6) 2013, the patient underwent treatment whereby a non-gore device was implanted to treat aaa enlargement to 70 mm.It was reported the enlargement was caused by disease progression, which contributed to persistent perfusion of the false lumen.The patient tolerated the procedure.This event was previously captured under event (b)(4).On (b)(6) 2014, follow up imaging showed the lesion measured 33 mm.On (b)(6) 2014 the proximal type i endoleak was treated by means of coil embolization.On (b)(6) 2015, follow up imaging showed the lesion measured 80 mm.On (b)(6) 2016, a proximal type i endoleak was identified.It was reported the proximal type i endoleak resulted in persistent perfusion of the false lumen through proximal flow from the tag3720.The proximal neck was reportedly too short to provide proximal seal for the dissection.It was reported there was no enlargement of the thoracic aortic dissection; however, the aaa reportedly enlarged from 80 mm on (b)(6) 2015 to 98 mm on (b)(6) 2016.On (b)(6) 2016, coil embolization was performed to treat the endoleak.It was reported the false lumen began in the region of the proximal thoracic aortic neck and terminated in the aaa sac.The right renal artery was reportedly perfused by the false lumen.The embolization with coils was performed through a fenestration in the dissection just below the right renal artery (in the free flow level), filling the sac of the false lumen.It was reported there was significant reduction in the blood flow to the false lumen at the end of the procedure; however, complete resolution of the endoleak reportedly could not be confirmed.There was a reported risk of occlusion risk of the right renal artery as the patient had chronic renal disease, so no further action was taken.It was reported the final result was satisfactory because there was almost complete exclusion of the aneurysmatic flow and preservation of flow to both renal arteries.The patient tolerated the procedure.On (b)(6) 2016 a ct revealed the aneurysm measured 94mm.On (b)(6) 2017, the aneurysm was shown to have decreased to 89mm and no endoleak was seen.The physician is monitoring the patient.

• Brand Name: GORE® TAG® THORACIC ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5812520
• MDR Text Key: 50132520
• Report Number: 2017233-2016-00644
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: TAG3720
• Device Lot Number: 8096386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2010
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 74