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

Catalog Number	PXC141200
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, this patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.The patient was lost to follow up in 2018, however returned for follow up on or about (b)(6) 2019.Computed tomography revealed a posterior contrast blush.The radiologist interpreted it as a type ii endoleak from an interior mesenteric artery.However, the physician determined it to be a type i distal endoleak.It appeared that the left contralateral leg component did not have sufficient distal seal.On (b)(6) 2019, the patient underwent a reintervention to treat the type i distal endoleak.An additional gore® excluder® aaa endoprosthesis contralateral leg component (plc161000/20743849) was implanted.The endoleak was resolved.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9239923
• Report Number: 2953161-2019-00062
• Device Sequence Number: 11235993
• Product Code: MIH
• UDI-Device Identifier: 00733132609956
• UDI-Public: 00733132609956
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2019

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: 11/30/2018
• Device Catalogue Number: PXC141200
• Device Lot Number: 14542411
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2019
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 85