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

Catalog Number	PXC201400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products-patient medications: vitamin k, losartan, coumadin, allopurinol, lipitor, glucotrol, coreg, klonopin, lasix, and aspirin.Gore imaging evaluation results-images were sent to gore imaging services for evaluation.Images received, one time-point is available for evaluation: post-implantation cta dated (b)(6) 2018.There appears to be lack of apposition at the distal end of the implanted device in the right common iliac artery (rci).The right internal iliac artery appears to be aneurysmal.The length from the distal end of the ipsilateral limb in the rci to the right iliac bifurcation appears to be ~4.2cm, by centerline.Diameters in the distal rci appear to range from 16.7mm (in distal device limb) ¿ 26.2mm.Diameters of the proximal 40mm of the right external iliac artery appear to range from ~8.7mm¿10.3mm.
Event or Problem Description
On (b)(6) 2011, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported there was a reintervention on (b)(6) 2018, to treat a type 1b endoleak on the previously implanted gore® excluder® aaa endoprosthesis (pxc201400/8472033).No aneurysm sac enlargement was present but there was lack of circumferential device apposition.The physician wanted to extend the limb of the graft into the external iliac artery.He embolized the internal iliac artery and then implanted a gore® excluder® aaa contralateral leg endoprosthesis (plc121400/18117685).The patient tolerated the procedure.

• 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: 8192403
• Report Number: 2017233-2018-00784
• Device Sequence Number: 2118893
• Product Code: MIH
• UDI-Device Identifier: 00733132610051
• UDI-Public: 00733132610051
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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: 09/30/2013
• Device Catalogue Number: PXC201400
• Device Lot Number: 8472033
• 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: 12/21/2018
• 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: 80 YR
• Patient Weight: 96