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	Positioning Failure (1158)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medical history includes but is not limited to: aaa, hypertension, gerd, hypercholesterolemia, arthritis, blindness, snoring, small cell lung cancer, diabetes, endoleak post evar.Concomitant medical products: patient medications include but are not limited to: amlodipine, cholecalciferol, famotidine, ferros sulfate, lisinopril.The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoleak, endoprosthesis: migration.A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Event or Problem Description
On (b)(6) 2017, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprosthesis featuring c3® delivery system.On (b)(6) 2020, follow-up imaging determined a distal type i endoleak originating from the contralateral leg component which is believed to have migrated proximally due to aneurysmal progression of the left common iliac artery.The physician plans to reintervene however a treatment plan has not yet been finalized.
Additional Manufacturer Narrative
B5: updated information.Images were provided to gore for evaluation and showed the following: images provided are post-implant cta dated (b)(6) 2020.Device migration is unable to be confirmed with one time-point.The length from the distal device limb to the left iliac bifurcation appears to be 78mm by centerline reconstruction.There appears to be a lack of wall apposition present at the distal end of the implanted graft on the left side.There does not appear to be pooling of contrast in the sac.
Event or Problem Description
There has been no reintervention performed or schedule todate.

• 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: 10900075
• Report Number: 3007284313-2020-01171
• Device Sequence Number: 1335780
• Product Code: MIH
• UDI-Device Identifier: 00733132618569
• UDI-Public: 00733132618569
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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: No Information
• Device Expiration Date: 01/11/2018
• Device Model Number: PLC231200
• Device Catalogue Number: PLC231200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 68 YR