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

Catalog Number RLT231218

Device Problem Collapse (1099)

Patient Problem Aneurysm (1708)

Event Date 05/05/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: patient medications: aspirin, lisinopril, and simvastatin.Additional devices implanted and/or related to this event: plc121400/18634295.

Event 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)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: rachael chascsa ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8656766
• MDR Text Key: 146622211
• Report Number: 3007284313-2019-00163
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622351
• UDI-Public: 00733132622351
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2022
• Device Catalogue Number: RLT231218
• Device Lot Number: 20153140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 78