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

Catalog Number	PXT231216
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2008 the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On (b)(6) 2019 the patient presented with a possible endoleak according to ultrasound diagnosis.The physician completed an angiogram that did not identify an endoleak.Reportedly the device appeared to be in good position from the original repair, and the aneurysm sac size appeared to be stable.It was reported that the physician suspected possible endotension.The decision was made to reline the original implanted gore® excluder® aaa endoprostheses.Reportedly 4 aptus endoanchor devices were placed at the proximal portion of the original trunk-ipsilateral leg component.The device was then relined with a pla230300 aortic extender component which was placed above the flow divider of the original main body.Both limbs were also relined.A plc141400 contralateral leg component was used to reline the original ipsilateral limb, located on the patient's right side.A plc121400 contralateral leg component was used to reline the original contralateral leg component located on the patient's left side.It was reported that implantation was completed without incidence.There were no further reported issues.The patient tolerated the procedure.
Additional Manufacturer Narrative
Additional system components involved in this adverse event include: item #pxc121200/ lot #04826437/ udi #(b)(4).H.6.Results code 1 updated.H.6.Results code 1: code 213 ¿ the review of the manufacturing paperwork verified that the lots met all pre-release specifications.H.6.Conclusions code 1 updated.H.6.Conclusions code 2 added.H.6.Conclusions code 2: code 22 - according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, endoleak.

• 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: 9200357
• Report Number: 2953161-2019-00060
• Device Sequence Number: 18944448
• Product Code: MIH
• UDI-Device Identifier: 00733132610112
• UDI-Public: 00733132610112
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

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: 11/30/2009
• Device Catalogue Number: PXT231216
• Device Lot Number: 04785807
• 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: 10/16/2019
• Supplement Report FDA Received Date: 10/24/2019
• 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: 82 YR
• Patient Weight: 100