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

Catalog Number	RMT231414
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the (manufacturing, sterilization, packaging, boxing) paperwork verified that this lot met all pre-release specifications.The gore® excluder® aaa endoprosthesis instruction for use (ifu) states, adverse events that may occur and/or require intervention include, but are not limited to endoleaks.
Event or Problem Description
On (b)(6) 2014, the patient had a full endovascular repair using gore® excluder® aaa endoprostheses.On an unknown date during a yearly ct scan the physician found a type 1b endoleak.On (b)(6) 2019, the patient had a re-intervention where two additional gore® excluder® aaa endoprostheses were implanted to extend distally into the iliac arteries.It was also reported that the internal iliac artery was coiled.The patient reportedly tolerated the procedure.
Additional Manufacturer Narrative
Date of re-intervention was (b)(6), 2019.Original entry was incorrect.
Additional Manufacturer Narrative
H6: code-213: the review of the manufacturing paperwork verified that this lot met all pre-release specifications.Corrected date of gore aware to 5/14/19.

• 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: 8629705
• Report Number: 2017233-2019-00365
• Device Sequence Number: 19421571
• Product Code: MIH
• UDI-Device Identifier: 00733132610556
• UDI-Public: 00733132610556
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2019

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: 01/31/2017
• Device Catalogue Number: RMT231414
• Device Lot Number: 12346945
• 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
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 06/04/2019; 06/25/2019
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 84