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

Catalog Number	PXL161407
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The gore® excluder® aaa endoprosthesis instructions for use (ifu) references risks occurring during or after implantation of the device, including potential for reintervention.
Event or Problem Description
On (b)(6) 2011, this patient underwent an endovascular repair for an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis featuring c3® delivery system.It was reported that distal to one of the implanted devices there is a tight stenotic lesion.There was a reintervention on (b)(6) 2019.The stenosis was on the left side and distal to the pxl161407/06400307 device.The physician implanted a gore® viabahn® vbx balloon expandable endoprosthesis and extended past the stenosis.The patient tolerated the reintervention procedure.
Additional Manufacturer Narrative
This medwatch will be retracted.Upon review of the file, this event does not meet the definition of a complaint.There is not any allegation that suggest the excluder caused or contributed to the event.

• 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: 8497849
• Report Number: 2953161-2019-00031
• Device Sequence Number: 1634037
• Product Code: MIH
• UDI-Device Identifier: 00733132610082
• UDI-Public: 00733132610082
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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): 06/05/2019

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: 10/31/2011
• Device Catalogue Number: PXL161407
• Device Lot Number: 06400307
• 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: 04/09/2019
• Supplement Report FDA Received Date: 06/05/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 58