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

Catalog Number	TGU404020
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: additional devices utilized in procedure are as follows: tgu454520, udi: (b)(4); tgu454515, udi: (b)(4); tgu454510, udi: (b)(4).It is not known which devices were involved in the type ii and type iii endoleaks, therefore all are being investigated.A review of the manufacturing records for the devices is currently in progress.
Event or Problem Description
The following information was reported to gore through the global registry for endovascular aortic treatment (great 10-11): on (b)(6) 2014, the patient underwent treatment of a descending thoracic aortic aneurysm whereby four conformable gore® tag® thoracic endoprosthesis were implanted distal to the brachiocephalic artery in zone 1.The patient tolerated the procedure.On (b)(6) 2015, follow up imaging showed the aneurysm measured 71 mm.On (b)(6) 2015, follow up imaging identified a proximal type i endoleak with aneurysm enlargement to 75 mm.On (b)(6) 2015, an additional aortic endograft (unknown type) was implanted for treatment of the endoleak.No further adverse events were reported.(captured event # (b)(4)) on (b)(6) 2018 the aneurysm measured 8.4cm x 7.9cm.On (b)(6) 2018 a type ii endoleak with thoracic aneurysm enlargement was identified.Additionally a type iii endoleak, described as component disconnection was also discovered.Relayplus endografts were used to treat the endoleaks.The components involved in the endoleaks were requested however they were not identified.
Additional Manufacturer Narrative
Results code 2: the review of the manufacturing evaluation verified that this lot met all pre-release specifications.Ctag lot 11809900 was propagated to ncr106960.This ncr was opened when two flip machines were discovered to have volumetric airflow sensors with calibration stickers past their calibration due date.The sensors were sent for calibration and were found to be within tolerance.Therefore the product processed through the flip machines were processed within the validated window.Based on the nature of the complaint and the investigation of ncr106960 there are no indications of a relationship between the ncr and the reported complaint.Conculusion code 2:22: according to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), "users are made aware of the risks associated with endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.".

• 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: 8425680
• Report Number: 2017233-2019-00149
• Device Sequence Number: 13902090
• Product Code: MIH
• UDI-Device Identifier: 00733132617760
• UDI-Public: 00733132617760
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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: 08/31/2016
• Device Catalogue Number: TGU404020
• Device Lot Number: 11820959
• 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: 03/15/2019
• Supplement Report FDA Received Date: 04/08/2019
• 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; Other; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 88