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

Model Number	TGT3115
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional gore® tag® conformable thoracic stent graft with active control system component to be included on this report: tgmr312610j / 20778495.(b)(4).Per the gore® tag® conformable thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to endoleak and aortic expansion (e.G., aneurysm, false lumen, landing zone, lesion).
Event or Problem Description
On (b)(6) 2010, the patient underwent endovascular treatment of a type b thoracic aortic dissection using gore® tag® thoracic endoprostheses.On an unknown date, a follow-up examination reportedly revealed a distal stent graft induced new entry (dsine), and false lumen expansion.On (b)(6) 2020 a re-intervention procedure was performed whereby a gore® tag® conformable thoracic stent graft with active control system was implanted to treat the dsine.The patient tolerated the procedure.(above event information has been captured in previous mfr report # 2017233-2020-01003) on an unknown date, follow-up imaging reportedly identified false lumen expansion, and a type iii endoleak (component disconnection) was suspected.The physician commented that a lack of sufficient overlap between the two distal gore® tag® devices may have contributed to this observation.On (b)(6) 2020, a re-intervention was performed whereby an additional gore® tag® device was implanted to reline the previously placed stent grafts.The patient tolerated the procedure.It was reported that a type ii endoleak was also observed on a final procedural angiograph, but the physician elected to monitor it and no further treatment was performed.

• Brand Name: GORE TAG THORACIC 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: 11013235
• Report Number: 2017233-2020-01528
• Device Sequence Number: 11667062
• Product Code: MIH
• UDI-Device Identifier: 00733132613625
• UDI-Public: 00733132613625
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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: 06/30/2013
• Device Model Number: TGT3115
• Device Catalogue Number: TGT3115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR