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

Model Number	RLT231418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: plc181400/22186335, udi: (b)(4).Concomitant medical products: patient medications: pepcid and calcium carb.
Event or Problem Description
On (b)(6) 2020, the patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® aaa endoprostheses.It was reported that on (b)(6) 2020, the patient presented at the emergency room with cold legs.Computed tomography scans revealed the proximal end of the trunk-ipsilateral leg endoprosthesis had folded over on itself (1800-e other/unknown).¿the flow divider was also kinked/folded like a pancake.¿ there was also thrombus throughout patients common/external iliac arteries.On (b)(6) 2020, the physician reintervened.He placed a 10x40mm palmaz stent in the proximal trunk-ipsilateral leg endoprosthesis up to renal arteries.Then placed two 11 x 59 vbx stents from the flow divider down distally.After those stents were placed, they relined the right common iliac artery with a contralateral leg endoprosthesis (plc181400).A contralateral leg endoprosthesis (plc141200) was placed in the left common iliac artery.An additional contralateral leg endoprosthesis (plc181200) was placed in the distal right common iliac artery to cover thrombus.Reportedly the patient did not have tortuous anatomy, it is unknown what caused the event.The patient tolerated the procedure.
Additional Manufacturer Narrative
Addition g5: addition computed tomography (cta) images dated (b)(6) 2020, were sent to gore imaging services for evaluation.Per the evaluation pre-implant cta dated (b)(6) 2020, revealed the proximal neck diameters range from 18 mm -19 mm.Proximal neck length appears to measure > 15 mm in length.Distal lci diameters range from 14 mm ¿ 15 mm.Lowest renal to liia 204 mm in length.Distal rci diameters range from 15 mm ¿ 17 mm.Lowest renal to riia 220 mm in length.Post implant cta dated november 11, 2020 revealed there appears to be a contrast-like density present outside of the deployed device, contrast cannot be confirmed with available image set.Portions of both the trunk-ipsi and contralateral leg grafts appears to be compressed and there appears to be thrombus throughout the grafts.

• 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: 10929080
• Report Number: 3007284313-2020-01177
• Device Sequence Number: 545921
• Product Code: MIH
• UDI-Device Identifier: 00733132622399
• UDI-Public: 00733132622399
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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: 08/03/2023
• Device Model Number: RLT231418
• Device Catalogue Number: RLT231418
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 01/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 127