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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: pxc121200/(b)(4)- udi: (b)(4).Patient medications include but are not limited to: allopurinol, eliquis, atorvastatin, levothyroxine, metoprolol, omeprazole, tamsulosin, aspirin, centrum silver.The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoleak, surgical conversion a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Event or Problem Description
On (b)(6) 2007, this patient underwent endovascular treatment for an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.On (b)(6) 2018, the patient was reported to have a type ii endoleak.The aneurysm sac was reported to measure 10cm.On (b)(6) 2018, the patient underwent explant of the devices and surgical repair of the abdominal aorta.It was reported that the source of the type ii endoleak was multiple lumbar arteries.The patient tolerated the procedure.The explanted devices were discarded at the site.
Additional Manufacturer Narrative
H6: code 213- a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Additional Manufacturer Narrative
Date gore aware: 9/28/18.
Additional Manufacturer Narrative
B3,b4: added/corrected information.

• 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: 7931207
• Report Number: 2953161-2018-00087
• Device Sequence Number: 13815373
• Product Code: MIH
• UDI-Device Identifier: 00733132610112
• UDI-Public: 00733132610112
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/16/2018

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: 07/31/2010
• Device Catalogue Number: PXT231216
• Device Lot Number: 05268214
• 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; Not provided; Not provided
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 10/10/2018; 10/30/2018; 11/19/2018
• 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; Other; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 78