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

Catalog Number	PXL161007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: pxl161407/9109192 (b)(4).Concomitant medical product(s): -patient medications: flomax, micardis, lopressor, klor-con, hygroton, lipitor, aspirin, norvasc, and synthroid.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use, warns that adverse events that may occur and /or require intervention include, but are not limited to endoleak and component migration.In addition the instructions for use (ifu), users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.
Event or Problem Description
On (b)(6) 2012, this patient underwent an endovascular repair for abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.Op notes provided for current reintervention revealed there was a reintervention in early 2019.The physician extended the left limb of the endoprosthesis (it is unknown which device was in the left limb and reintervened on) into the external iliac artery to provide better seal and did a transcaval coiling where flow channel was accessed and treated.The patient tolerated this reintervention.There was aneurysm sac enlargement with an unknown cause.It was reported that images (date and modality is unknown) revealed a possible type ii endoleak and aneurysm sac enlargement.On (b)(6) 2019, there was a reintervention.The physician chose to reline the gore® excluder® aaa endoprosthesis and anchor proximally.The patient tolerated the reintervention.

• 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: 9207763
• Report Number: 2953161-2019-00061
• Device Sequence Number: 305229
• Product Code: MIH
• UDI-Device Identifier: 00733132610068
• UDI-Public: 00733132610068
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 09/20/2019

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: 09/30/2018
• Device Catalogue Number: PXL161007
• Device Lot Number: 14432130
• 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: 10/18/2019
• 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