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

Catalog Number	PXT261418
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patient medications include but are not limited to: humira, arava, folic acid, prednisone, hydrocodone, aspirin, amlodipine besylate, hyzaar, klor-con, basaglar kwikpen, novolog, metformin, crestor, proair resplickick, singulair, zytec, stool softener.According to the instructions for use (ifu) for the gore® excluder® aaa endoprostheses; adverse events that may occur include, but are not limited to include: aneurysm enlargement.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) 2009, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2019, the patient underwent reintervention occurred and a gore® aortic extender component was placed proximally.The type of endoleak was unable to determined.As there was also bird beaking of the proximal end of the trunk on the right side, a palmaz stent was also placed.The patient was reported to have a short angled neck (unknown if angle exceeded 60 degrees).It was also reported there was enlargement of the aneurysm from 6 x 5.8cm in diameter on (b)(6) 2018 to 7.4cm in diameter on (b)(6) 2018.At time of reintervention the diameter measured 7.7 x 7.0cm.The patient tolerated the procedure well.

• 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: 8422954
• Report Number: 2953161-2019-00025
• Device Sequence Number: 2227505
• Product Code: MIH
• UDI-Device Identifier: 00733132610242
• UDI-Public: 00733132610242
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

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: 09/30/2011
• Device Catalogue Number: PXT261418
• Device Lot Number: 06365398
• 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: 03/14/2019
• 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; Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 93