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

Model Number RLT261416

Device Problem Obstruction of Flow (2423)

Patient Problem Numbness (2415)

Event Date 01/13/2022

Event Type  Injury  

Event Description

On (b)(6) 2021, the patient was treated for an iliac aneurysm.The physician implanted a gore® excluder® aaa endoprosthesis featuring c3® delivery system, a gore® excluder® aaa endoprosthesis, a gore® excluder® iliac branch endoprosthesis, and a gore® viabahn® endoprosthesis with heparin bioactive surface.The patient tolerated the procedure.On the one month follow up visit, it was reported limb compression occurred in the gate area of the main body, causing left leg claudication.The physician plans to reintervene on (b)(6) with kissing vbx stents at the level of the main body flow divider.Received information from fsa.Reintervention was performed on (b)(6) 2022.Physician gained bilateral access and placed bilateral kissing 11 mm vbx stents in the compressed area of the limb.Ivus confirmed patency.Physician reports palpable pulses on the left foot which were previously absent.

Manufacturer Narrative

H6: investigation findings: code 3233 updated to code 213.H6: investigation conclusions: code 11 updated to code 4315.H6: type of investigation code 4118 updated to code 3331 with completion of phr review.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13484689
• MDR Text Key: 289349254
• Report Number: 3007284313-2022-01766
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622467
• UDI-Public: 00733132622467
• 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,Followup
• Report Date: 05/23/2022

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 Model Number: RLT261416
• Device Catalogue Number: RLT261416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 05/23/2022
• Supplement Dates FDA Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male