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

Model Number	PXT261214
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2011, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.The treatment was completed without any issues after placing pxt261214 from the right side and pxc141400 in the left side of the patient.In (b)(6) 2012 (date is unknown), the follow-up examination showed no anomalies.The aneurysm diameter was approximately 41 x 43 mm.In (b)(6) 2018 (date is unknown), the follow-up examination showed no change in the aneurysm size.In (b)(6) 2019 (date is unknown), the follow-up examination showed aneurysm enlargement.The diameter was approximately 45 x 51 mm.In (b)(6) 2020 (date is unknown), a follow-up examination revealed that the aneurysm diameter expanded to 54 x 58 mm.Based on computed tomography (ct), no obvious endoleak was identified.On (b)(6) 2020, additional treatment was performed.As the landing zones of the proximal neck of the main body and the distal neck of the right leg were slightly short, proximal and distal type i endoleaks were suspected.However, no endoleak was identified by angiography.As a prevention, stentgrafts were additionally implanted both in the proximal and the distal to the index devices respectively.There was no endoleak after implantation.The final angiography revealed that there was a possibility of type ii endoleak from the lumbar artery.The physician decided to monitor and the procedure was completed.
Additional Manufacturer Narrative
Date of event - corrected to (b)(6) 2019, as aneurysm enlargement was first observed on an unknown date in that month it is unknown which gore device contributed to the aneurysm enlargement, so pxc141400/88177938 will be included in this report code 22 ¿ according to the gore® excluder® aaa endoprosthesis instructions for use, adverse events with may occur and/or require intervention including, but not limited to, endoleak and aneurysm enlargement.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10135766
• Report Number: 2017233-2020-00422
• Device Sequence Number: 5760539
• Product Code: MIH
• UDI-Device Identifier: 00733132610181
• UDI-Public: 00733132610181
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2020

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: Health Professional
• Device Expiration Date: 01/31/2014
• Device Model Number: PXT261214
• Device Catalogue Number: PXT261214
• Device Lot Number: 8848549
• 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: 06/09/2020
• Supplement Report FDA Received Date: 06/15/2020
• 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: Required Intervention
• Patient Age: 88 YR