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

Model Number	PLC231200
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the manufacturing records indicated the lot met pre-release specifications.The device remains implanted in the patient.Imaging series have been requested and provided for investigation.Imaging series are being evaluated.
Event or Problem Description
On (b)(6) 2018, the patient presented with an aortic aneurysm reaching to the iliac artery which was treated with a gore® excluder® aaa endoprosthesis and a gore® excluder® iliac branch endoprosthesis.On (b)(6) 2020, a computed tomography angiography suggested an endoleak.On (b)(6) 2020, an angiography confirmed that the bridging contralateral leg endoprosthesis (plc231200) disconnected resulting in a type iii endoleak.Growth of the aneurysmal sac was noticed.On (b)(6) 2020 the endoleak was resolved during a reintervention.The bridge was extended with another contralateral leg endoprosthesis (plc271200).
Additional Manufacturer Narrative
H6-code 4112: imaging series have been provide and were evaluated.The imaging evaluation summary states the following: two time-points available for evaluation: post-implantation cta dated (b)(6) 2019 and post-implantation cta dated (b)(6) 2020.On the (b)(6) 2019 time-point no endoleak is visualized or device separation.On the (b)(6) 2020 time-point there appears to be a gap between the distal contralateral leg ¿bridging¿ device and the proximal ibe trunk.Contrast appears to be pooling in the sac at this location of device separation in the rci.Type iii endoleak appears to be confirmed.Aneurysm sac size appears to change between time-points: o (b)(6) 2019¿ 45.2 mm x 52.4 mm; o (b)(6) 2020¿ 53.3 mm x 57.3 mm.

• Brand Name: GORE EXCLUDER AAA 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: 10842790
• Report Number: 3013164176-2020-01078
• Device Sequence Number: 11695642
• Product Code: MIH
• UDI-Device Identifier: 00733132618569
• UDI-Public: 00733132618569
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P020004
• 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,Followup
• Report Date (Section B): 12/04/2020

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: 06/12/2021
• Device Model Number: PLC231200
• Device Catalogue Number: PLC231200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 12/05/2020
• 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
• Patient Age: 64 YR