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

Model Number	PXC121400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products - patient medications: albuterol, symbicort, simvastatin, lisinopril, hygroton, zyloprim, luteen, synthroid, and multivitamin.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to endoleak.
Event or Problem Description
On (b)(6) 2010, this patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that a possible distal type i b endoleak was present which was causing aneurysm sac enlargement (amount is unknown).Reportedly there was a past attempt (date is unknown) to embolize a type ii endoleak, the field sales associate was not present and not aware of any intervention¿s until notified during the reintervention procedure on (b)(6) 2020.On (b)(6) 2020, the physician reintervened and coiled proximally up into the aneurysm sac of the left contralateral side of device and then implanted a gore® excluder® aaa contralateral leg endoprosthesis to extend the implanted graft.The patient tolerated the reintervention.
Additional Manufacturer Narrative
Addition g5.
Additional Manufacturer Narrative
Addition additional devices implanted and/or related to this event: pxt231418/7380026.Addition 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.

• 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: 9795494
• Report Number: 2953161-2020-00006
• Device Sequence Number: 2411462
• Product Code: MIH
• UDI-Device Identifier: 00733132609932
• UDI-Public: 00733132609932
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2020

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: 02/28/2013
• Device Model Number: PXC121400
• Device Catalogue Number: PXC121400
• Device Lot Number: 7672540
• 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: 03/05/2020
• Supplement Report FDA Received Date: 03/05/2020; 04/21/2020
• 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: 84 YR
• Patient Weight: 119