MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	RLT231214
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy dates: (b)(6) 2019: pll161207/20484379 udi: (b)(4).
Event or Problem Description
On (b)(6) 2019, this patient underwent an endovascular procedure to treat a "significant chunk of thrombus" that was attached to the distal aorta near the aortic bifurcation.The thrombus was showering into the patients legs.The physician planned to trap the thrombus against the distal aorta using a gore® excluder® aaa endoprosthesis featuring c3 deployment system.The trunk-ipsilateral leg component was implanted with the ipsilateral leg on the right side, and the contralateral leg component on the left side.An iliac extender component was also implanted on the right side.Later on the same day, the physician reported that the ipsilateral side of the trunk-ipsilateral component and the iliac extender component had become occluded.It is believed that the thrombus in the distal aorta was pushing against the ipsilateral leg and blood flow was hindered from going down the ipsilateral side, thus contributing to the occlusion.On (b)(6) 2019, both gore devices were explanted.An aorto-uni-iliac bypass was performed on the patient¿s right side, and an aorto-femoral bypass was completed on the patient¿s left side.The patient tolerated the procedure.No other information was given, and due to hippa no other details are expected.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9278593
• Report Number: 3007284313-2019-00336
• Device Sequence Number: 10867332
• Product Code: MIH
• UDI-Device Identifier: 00733132622337
• UDI-Public: (01)00733132622337(17)201129
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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: 11/29/2020
• Device Model Number: RLT231214
• Device Catalogue Number: RLT231214
• Device Lot Number: 17502746
• 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
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/13/2019
• 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; Required Intervention
• Patient Age: 62 YR