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

Catalog Number	TGU262110
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/19/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), the gore® tag® thoracic endoprosthesis is not recommended in patients with known sensitivities or allergies to eptfe, fep, gold, nickel, or titanium.Complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to: allergic reaction (e.G., to contrast, anti-platelet therapy, stent graft material).Medications benadryl oral and topical, aspirin, heart burn medications (type unknown), medical marijuana, and over the counter medications (types unknown).The review of the manufacturing paperwork verified that these lots met all pre-release specifications.Additional devices implanted: tgu312610/10265476 and tgu313110/10483573.(b)(4).
Event or Problem Description
On (b)(6) 2015, the patient was treated for a thoracic aortic aneurysm using conformable gore® tag® thoracic endoprostheses.It was reported metal clips (manufacturer unknown) were left behind in the patient¿s right femoral artery.It was reported ¿days¿ after the surgery the patient was experiencing severe itching that has lasted 3.5 years.The patient reportedly underwent an allergy test at a dermatologist confirming the patient has a nickel allergy.The patient is reportedly being monitored.

• 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: 7835886
• Report Number: 2017233-2018-00526
• Device Sequence Number: 1981407
• Product Code: MIH
• UDI-Device Identifier: 00733132617791
• UDI-Public: 00733132617791
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

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: 12/31/2016
• Device Catalogue Number: TGU262110
• Device Lot Number: 12207341
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2018
• 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: Other
• Patient Age: 57 YR