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

Model Number	PLA280300
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	02/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the devices verified the lots met all pre-release specifications.Also was involved rlt281416/21129344 udi# (b)(4).The devices remain in the patient and are not available for analysis.Images were provided to gore for analysis.Only one time-point pre-implantation cta dated (b)(6) 2019 was available for evaluation.The right renal artery is the lowest renal.The aortic diameter just distal to the right renal appears to be 24.0mm.The aortic diameter about 8mm distal to the right renal appears to be 22.9mm.The aortic diameter 15mm distal to the right renal appears to be 30.8mm.There appears to be some thrombus within this 15mm of abdominal aorta.There appears to be about 11mm of diameters distal to the right renal artery within a device size.There does not appear to be an angle within the proximal 15mm of abdominal aorta.Aortic angulation distally appears to be 36 degrees.As reported by the physician the deployment inaccuracy may cause migration.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to component migration and occlusion of native vessel.Do not cover significant renal or mesenteric arteries with the endoprosthesis.Vessel occlusion may occur.Incorrect deployment or migration of the endoprosthesis may require surgical intervention.Ifu states: additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.An infrarenal non-aneurysmal aortic neck length has to be at least 15 mm.Key anatomic elements that may affect successful exclusion of the aneurysm include short proximal aortic neck and significant thrombus at the arterial implantation sites, specifically the proximal aortic neck and distal iliac iliac artery interface.The pre-treatment images revealed that the aortic neck length was 11mm.Per ifu an infrarenal non-aneurysmal aortic neck length has to be at least 15 mm.
Event or Problem Description
On (b)(6) 2020, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.Reportedly, during the procedure, the gore® excluder® aaa endoprosthesis featuring c3® delivery system migrated distally a little (distance unknown) and the physician decided to implant the aortic cuff.Upon deployment, the gore® excluder® aaa endoprosthesis aortic extender component jumped forward and covered both renal arteries.The physician managed to get an oscar sheath into both renal arteries fast and pulled down the extender fabric, and placed atrium stents in the renal arteries.An excellent final result was achieved.Reportedly, there was nothing in patient¿s anatomy caused or contributed to the event.As reported by the physician the deployment inaccuracy may cause migration.The patient tolerated the procedure and on (b)(6) 2020 was discharged from the hospital.
Additional Manufacturer Narrative
Additional information: g: section 5;.H6: method code 2.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9714811
• Report Number: 3013164176-2020-00026
• Device Sequence Number: 14353273
• Product Code: MIH
• UDI-Device Identifier: 00733132618781
• UDI-Public: 00733132618781
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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: 02/28/2022
• Device Model Number: PLA280300
• Device Catalogue Number: PLA280300
• Device Lot Number: 20298448
• 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
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/10/2020
• 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: 76 YR