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

Model Number	PXT281414
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2008, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2021, the physician reported this patient has a type ii endoleak (source unknown) with aneurysm enlargement (amount unknown).Patient is scheduled for an angio on (b)(6)2021.On (b)(6) 2021, the patient underwent reintervention to treat the type ii endoleak which appeared to originate from the left internal iliac artery (liia).Two distal branches were coiled using penumbra ruby coil® s via the liia.The patient tolerated the procedure and the endoleak was resolved.Aneurysm enlargement was confirmed however the amount of enlargement remained unknown.
Additional Manufacturer Narrative
Patient medical history includes but is not limited to: gerd, hypertension.Patient medications include but are not limited to: ranitidine, tamsalosin, trymesilam, carbamazepine atenolol, amalodapine, aspirin, citalopram, finastride, perstatin, metroperol, niacin 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.
Additional Manufacturer Narrative
Images were provided to gore for evaluation and showed the following: one time-point available for evaluation: post-implantation cta dated (b)(6) 2021.Comparison series (non-contrast, arterial contrast and delayed contrast) of axial imaging appears to show: there appears to be a metallic-like density outside the left/anterior aorta.Possible embolization of the ima.There appears to be contrast pooling in the right posterior sac, on the arterial contrast series.Possible lumbar involvement but cannot confirm without visualized communication.There appears to be another pooling of contrast outside the implanted devices in the left side of the aneurysm sac on the arterial contrast series, distal to the first pooling.There appears to be two different pooling¿s of contrast in the aneurysm sac.Cannot confirm endoleak origin(s) with available imaging.
Additional Manufacturer Narrative
H6: component code 4755 added.

• 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
• Manufacturer (Section G): MEDICAL WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12761638
• Report Number: 2017233-2021-02518
• Device Sequence Number: 11556041
• Product Code: MIH
• UDI-Device Identifier: 00733132610303
• UDI-Public: 00733132610303
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2022

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: 12/31/2009
• Device Model Number: PXT281414
• Device Catalogue Number: PXT281414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 10/12/2021; 03/28/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/20/2021; 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 97 KG