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

Catalog Number	TGU343420
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Claudication (2550); Vascular Dissection (3160); Not Applicable (3189)
Date of Event	06/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the conformable gore® tag® thoracic endoprosthesis may include but are not limited to vascular trauma and claudication.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2016 a patient underwent treatment of a type b complicated aortic dissection with a conformable gore® tag® thoracic endoprosthesis.The maximum aortic diameter measured 46.4mm.On (b)(6) 2018 the patient exhibited left lower limb claudication and underwent an additional endovascular repair of the thoracic dissection.Additionally a left common iliac artery external iliac artery stent angioplasty was performed.The patient tolerated the procedure.
Event or Problem Description
The following information was reported to gore: on (b)(6), 2016 a patient underwent treatment of a type b complicated aortic dissection extending to the iliac arteries with a conformable gore® tag® thoracic endoprosthesis.The maximum aortic diameter measured 46.4mm.As part of the planned staged treatment for this patient, an axillary femoral bypass procedure was also performed.On (b)(6), 2018 the patient exhibited left lower limb claudication, which appeared to be related to true lumen compression in the left iliac system, and underwent an additional endovascular repair of the thoracic dissection with two conformable gore® tag® thoracic endoprostheses.Additionally the left common iliac artery was treated with a gore® viabahn® vbx balloon expandable endoprosthesis and the left external iliac artery was treated with a zilver stent.The patient tolerated the procedure.
Additional Manufacturer Narrative
Updated.
Additional Manufacturer Narrative
Upon further review of the event, there is no allegation against the gore devices.The additional procedures were part of a planned, staged treatment.Although the patient did experience claudication, the claudication was not an embolic or device related event.Rather it was related to compression in the iliac system.Medwatches # 2017233-2018-00652 were sent in error.Additional received information determined that this event is not reportable to the fda and therefore the medwatch and supplemental reports are being retracted.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8011730
• Report Number: 2017233-2018-00652
• Device Sequence Number: 19191479
• Product Code: MIH
• UDI-Device Identifier: 00733132618170
• UDI-Public: 00733132618170
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2019
• Device Catalogue Number: TGU343420
• Device Lot Number: 15379440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/28/2018
• Supplement Report FDA Received Date: 11/21/2018; 12/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 58