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

Catalog Number	TGU454520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	06/19/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Results: a review of the manufacturing records for the device verified the lot met all pre-release specifications.Conclusions: according to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the conformable gore® tag® thoracic endoprosthesis may include but are not limited to cardiac arrhythmia and death.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 a patient was undergoing treatment of an aortic dissection.The patient had a prior implantation of a cook alpha device.The treatment was a combined endovascular and open procedure.A gore® tag® thoracic endoprosthesis was advanced and deployed.A vascutek thoraflex device was also advanced and deployed.The branches of the thoraflex device were extended with gore® propaten® vascular grafts to the visceral arteries: sma, and both renals.Immediately following ballooning of the aortic devices, the patient had a cardiac arrest.Defibrillation and chest compressions were performed.The patient was stabilized and taken to recovery.All devices were patent and functioning at the close of the procedure, however the patient's condition was considered dire.On (b)(6) 2018 the patient expired due to disseminated intravascular coagulation.

• 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: 7653760
• Report Number: 2017233-2018-00362
• Device Sequence Number: 16522110
• Product Code: MIH
• UDI-Device Identifier: 00733132617753
• UDI-Public: 00733132617753
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

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: 03/25/2021
• Device Catalogue Number: TGU454520
• Device Lot Number: 17995850
• 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: 06/30/2018
• 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: Death
• Patient Age: 61 YR
• Patient Weight: 181