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

Model Number	RMT261414
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy dates: amlodipine 10mg, sertraline 50mg, lasix 40mg, omeprazole 20mg, oxycontin 20mg.(b)(4).
Event or Problem Description
On (b)(6) 2014 the patient underwent endovascular repair using gore® excluder® aaa endoprostheses.It was reported that the patient was lost to follow up.The patient's medical records show that a cta of the patient's abdomen and pelvis was performed in (b)(6) 2019 which did not demonstrate an endoleak, and the native aneurysm sac measured 7.7cm.On an unknown date the patient was admitted to an outside hospital after a fall.Reportedly a ct scan was performed on the patient's abdomen and pelvis, date unknown.Aneurysm enlargement was reported.The amount of aneurysm enlargement is reportedly unknown, and the patient's medical records showed that the aneurysm sac measured approximately 7.7cm.A proximal type i endoleak was reported to be the cause of aneurysm enlargement.The cause of the endoleak was reported to be loss of proximal wall apposition of the device.The patient's aortic neck was reported to be long, but had thrombus or atheroma that was holding the proximal end of the device away from the wall of the aorta.The cta also reportedly revealed a possible type ii endoleak.No reintervention has been performed, as the patient requires time to recover from the fall and subsequent left hip fracture.The patient has been instructed to follow up with the implanting physician regarding the endoleak.The endoleak is reported in the patient's medical records as a chronic problem with no emergent requirements.

• 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: 9757284
• Report Number: 3007284313-2020-00056
• Device Sequence Number: 2185617
• Product Code: MIH
• UDI-Device Identifier: 00733132610631
• UDI-Public: 00733132610631
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 01/28/2020

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: 04/30/2016
• Device Model Number: RMT261414
• Device Catalogue Number: RMT261414
• Device Lot Number: 11513911
• 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: 02/26/2020
• 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: Other
• Patient Age: 85 YR
• Patient Weight: 50