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

Model Number TGMR373720

Device Problem No Apparent Adverse Event (3189)

Patient Problems Aneurysm (1708); Vascular Dissection (3160)

Event Date 06/28/2020

Event Type  Death  

Manufacturer Narrative

Patient medical history includes but is not limited to: tevar, extreme hypertension.Patient medications include but are not limited to: labetalol, losartin, lasix.A review of the manufacturing records for the device was unable to be conducted as no lot number was available; as such, no udi was generated.According to the instructions for use (ifu) for the gore® tag® thoracic endoprosthesis; adverse events that may occur include, but are not limited to: dissection, perforation, or rupture of the aortic vessel and surrounding vasculature.

Event Description

On (b)(6) 2020, this patient underwent endovascular treatment for a descending thoracic aortic aneurysm and was implanted with two conformable gore® tag® thoracic endoprostheses (ctag).The patient tolerated the procedure.It was noted that the patient had a bovine arch.On (b)(6) 2020, the patient presented emergently with a ruptured thoracic type b dissection and underwent surgical bypass of the left subclavian artery to the innominate artery.Additionally, an aorta bi-fem bypass of the superior mesenteric artery to the renals was performed.An additional ctag was implanted within the surgical graft and extended down to the abdominal aorta.The patient tolerated the procedure however is still under anesthesia.The physician reports the rupture is thought to have been due to persistent perfusion into the false lumen and thrombosis of the false lumen.There was no allegation of deficiency as to the devices by the physician, all devices performed as intended.

Event Description

On (b)(6) 2020, it was reported that the patient expired.A cause of death was unknown.

Manufacturer Narrative

Updated/corrected information: d11: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: tgm454515/21961607.

Manufacturer Narrative

H6: code 213- a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

• 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
• MDR Report Key: 10215523
• MDR Text Key: 197098653
• Report Number: 2017233-2020-01008
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: TGMR373720
• Device Catalogue Number: TGMR373720
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other; Required Intervention
• Patient Age: 28 YR
• Patient Weight: 105