MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	PLA360400
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Sudden Cardiac Death (2510); No Code Available (3191)
Date of Event	02/03/2015
Type of Reportable Event	Death
Additional Manufacturer Narrative
This medwatch report is associated with mfr report # 2017233-2018-00321.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2014, this patient underwent endovascular treatment for a thoracic aneurysm of the descending aorta measuring 48 mm in diameter.The patient was therefore treated with a conformable gore® tag® thoracic endoprosthesis.On (b)(6) 2015, a type 1a endoleak was diagnosed and a gore® excluder® aortic extender component pla360400 was implanted in an attempt to solve the endoleak situation.On (b)(6) 2015, follow-up computed tomography angiography imaging (cta) revealed an aneurysm diameter of 98 mm.With an onset date of (b)(6) 2015, the type 1a endoleak was reported to persist.On the same day, a fenestrated prosthesis was implanted to repair the endoleak.On (b)(6) 2015, additional follow-up cta imaging was performed and identified an aneurysm diameter of 100 mm.On (b)(6) 2015, follow-up imaging diagnosed a ruptured aneurysm and on (b)(6) 2015, additional cta imaging revealed an ongoing aneurysm enlargement with a diameter of 105 mm.On (b)(6) 2015, the patient was reported to have expired following the aortic rupture.
Additional Manufacturer Narrative
(b)(4).According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), complications associated with the use of the gore® excluder® aaa endoprosthesis may include but are not limited to: endoleaks.Please note: this medwatch report is associated with mfr report # 2017233-2018-00321.
Additional Manufacturer Narrative
Updated event description.Please note: implant date (b)(6) 2015, replaces the previously reported implant date (b)(6) 2015, for the jotec® fenestrated prosthesis implanted to repair the type 1a endoleak.Onset date for the identification of the persisting type 1a endoleak of (b)(6) 2015, replaces the previously reported onset date of (b)(6) 2015.Medical history: "previous aortic repair of descending arch" is withdrawn as found incorrect.Please note: this medwatch report is associated with mfr report # 2017233-2018-00321.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2014, this patient underwent endovascular treatment for a thoracic aneurysm of the descending aorta measuring 48 mm in diameter.The patient was therefore treated with a conformable gore® tag® thoracic endoprosthesis.On (b)(6) 2015, a type 1a endoleak was diagnosed and a gore® excluder® aortic extender component pla360400 was implanted in an attempt to solve the endoleak situation.On (b)(6) 2015, follow-up computed tomography angiography imaging (cta) revealed an aneurysm diameter of 98 mm.On (b)(6) 2015, follow-up cta identified a diameter of 100 mm and the type 1a endoleak was found to persist.On (b)(6) 2015, a jotec® fenestrated endoprosthesis was additionally implanted to remedy the type 1a endoleak.On (b)(6) 2015, follow-up imaging diagnosed a ruptured aneurysm and on (b)(6) 2015, additional cta imaging revealed an ongoing aneurysm enlargement with a diameter of 105 mm.On (b)(6) 2015, the patient was reported to have expired due to internal bleeding following the aortic rupture.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7638427
• Report Number: 3007284313-2018-00189
• Device Sequence Number: 13901866
• Product Code: MIH
• UDI-Device Identifier: 00733132618439
• UDI-Public: 00733132618439
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2018

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: 08/31/2016
• Device Catalogue Number: PLA360400
• Device Lot Number: 11816321
• 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; Not provided
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 09/07/2018; 09/07/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 80