MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (VER 1.5); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	TGT4520
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore tag® thoracic endoprosthesis instructions for use (ifu), the gore® tag® thoracic endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.Also, the ifu states, complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to aortic rupture, endoleak and reoperation.
Event or Problem Description
On (b)(6) 2013, the patient underwent treatment of a thoracic aortic aneurysm located in the aortic arch using a gore tag® thoracic endoprosthesis (tgt4520/10762704).During the same procedure, the thoracic arch branch vessels were bypassed and a stent graft was implanted into one of the branch vessels (¿chimney technique¿).In (b)(6) 2018, a follow-up computed tomography scan showed there was no endoleak or aneurysm enlargement.It was reported that on (b)(6) 2019, the thoracic aortic aneurysm was ruptured.The patient was transferred to the hospital and underwent an emergent re-intervention in order to treat the rupture.During the re-intervention, an intra-operative angiography showed a suspected type iii endoleak.The physician thought that it was a fabric type iii endoleak.A conformable gore tag® thoracic endoprosthesis (tgu454520j) was implanted to treat the endoleak.The endoleak was resolved.The patient tolerated the procedure.The physician reported that the endoleak was not originating from the chimney device in the branch vessel.A friction between the fabric and the stent might have contributed to the fabric type iii endoleak.
Additional Manufacturer Narrative
Several time-points images were submitted to gore for evaluation.Endoleaks cannot be evaluated on non-contrast studies.Post-implantation cta on (b)(6) 2019 appears to show contrast pooling in the aneurysmal sac outside the implanted device.Angiogram images on (b)(6) 2019 appear to show contrast outside the implanted device with a ¿blushing¿ effect.There appears to be 2 devices implanted by the end of the angiogram study on (b)(6) 2019.Although actual deployment of a second device is not included with submitted angio imaging.Comparison axial images of on (b)(6) 2019 cta and on (b)(6) 2019 cta appear to show: contrast pooling in the aneurysm sac on (b)(6) 2019 images.There appears to be 2 devices implanted on (b)(6) 2019 images.There appears to be resolution of the endoleak on (b)(6) 2019 time point.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (VER 1.5)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8529350
• Report Number: 2017233-2019-00263
• Device Sequence Number: 2516125
• Product Code: MIH
• UDI-Device Identifier: 00733132613748
• UDI-Public: 00733132613748
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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: 09/30/2015
• Device Catalogue Number: TGT4520
• Device Lot Number: 10762704
• 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
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 06/10/2019
• 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; Required Intervention
• Patient Age: 88 YR