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

Model Number	PXC201000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2009, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On (b)(6) 2020, films were read by the gore field sales associate that revealed the contralateral leg component in the left common iliac artery was now "floating in the aneurysm sac.On (b)(6) 2020, a reintervention occurred whereby additional components were implanted to treat the lack of circumferential device apposition.
Additional Manufacturer Narrative
H10/11: additional manufacturer narrative/corrected data: additional information received: the physician stated that the cause of the lack of circumferential device apposition was disease progression.H6: result code 1, conclusion code 1, conclusion code 2.

• 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: 9788676
• Report Number: 3007284313-2020-00060
• Device Sequence Number: 1865661
• Product Code: MIH
• UDI-Device Identifier: 00733132610037
• UDI-Public: 00733132610037
• 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: 2009
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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: 05/31/2012
• Device Model Number: PXC201000
• Device Catalogue Number: PXC201000
• Device Lot Number: 06803590
• 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: 03/04/2020
• Supplement Report FDA Received Date: 04/01/2020
• 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 Weight: 81