MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGU373715
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #:tgu373715/ serial #: (b)(4) / udi #: (b)(4).Date of event: as the date of identification of the type ii endoleak was not provided, the date of event has been estimated as the date of reintervention: (b)(6)2016.Concomitant medical products and therapy dates: unavailable.Investigation conclusions: code 22 - according to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® thoracic endoprosthesis include, but are not limited to, endoleak and reoperation.Furthermore, the ifu states, if coverage of the left subclavian artery ostium is required to obtain adequate neck length for fixation and sealing, transposition or bypass of the left subclavian artery should be considered.In addition, consider occlusion of the ostium via surgical or endovascular means to avoid type ii endoleaks.
Event or Problem Description
On (b)(6) 2016 the patient underwent endovascular treatment of a type b uncomplicated aortic dissection using two conformable gore® tag® thoracic endoprostheses.It was noted that the proximal portion of the proximal device was deployed in zone 1 distal to the patient's brachiocephalic artery.The patient was discharged on (b)(6) 2016.On an unknown date a type ii endoleak was identified originating from the patient's left subclavian artery (lsa).On (b)(6) 2016 the patient was admitted for pre-operative hydration for an lsa coil embolization procedure to treat the type ii endoleak.A left brachial approach was used and multiple terumo azur coils were placed in the lsa.It was reported that final angiography confirmed very minimal flow into the lsa.No complications were reported.There were no further reported issues.The patient tolerated the intervention.

• Brand Name: CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12256462
• Report Number: 2017233-2021-02209
• Device Sequence Number: 4848055
• Product Code: MIH
• UDI-Device Identifier: 00733132618187
• UDI-Public: 00733132618187
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2021

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: 02/02/2019
• Device Model Number: TGU373715
• Device Catalogue Number: TGU373715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/30/2021
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 73