MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	RLT231218
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patient medications: aspirin, lisinopril, and simvastatin.Additional devices implanted and/or related to this event: plc121400/18634295.
Event or Problem Description
On (b)(6) 2019, this patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.Reportedly, prior to the (b)(6) 2019 procedure, there was a previous stented dissection that was present before the endograft placement in the distal right common iliac artery with a 12mm x 30mm self-expanding stent.It was reported the patient presented to the hospital on (b)(6) 2019, with symptoms of an ischemic right leg.Computed tomography revealed a compression of the proximal gore® excluder® aaa contralateral leg endoprosthesis limb at the level of the bifurcation of the endograft.Both the rlt231218 and plc121400 devices were compressed at the proximal area of overlap, both limbs were in an area where the aorta measures 16mm total.There is a ct on post op day one that shows this, but the images are not available to gore for evaluation.The physician reintervened and deployed an 8mm x 27mm balloon expandable bare metal stent and post dilated to 10mm.Angiogram revealed resolution of compression and palpable pulse returned to the right groin.The final angiogram showed no sign of extravasation.The patient tolerated the reintervention procedure.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8656766
• Report Number: 3007284313-2019-00163
• Device Sequence Number: 16616646
• Product Code: MIH
• UDI-Device Identifier: 00733132622351
• UDI-Public: 00733132622351
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2019

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: 01/24/2022
• Device Catalogue Number: RLT231218
• Device Lot Number: 20153140
• 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: 05/30/2019
• 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; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 78