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

Model Number RLT281412

Device Problem Collapse (1099)

Patient Problem Obstruction/Occlusion (2422)

Event Date 06/17/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the patient was treated for an abdominal aortic aneurysm.The physician implanted a gore® excluder® aaa endoprosthesis featuring c3® delivery system and three gore® excluder® aaa endoprostheses.During the surgery, the rlt281412 collapsed, and a limb occlusion occurred.The physician converted to an open procedure, explanting the grafts and implanting dacron grafts.The patient tolerated the procedure.The patient was reported to have a connective tissue disorder and numerous dissections.

Manufacturer Narrative

Images were returned for evaluation: ¿ two time-points available for evaluation: pre-implantation cta dated (b)(6) 2021 and post-implantation cta dated (b)(6) 2021.¿ pre-implantation 3d image appears to show dissection in the rci.¿ axial images appear to confirm the dissection in the rci.¿ pre-implantation axial imaging also appears to show a dissection in the left internal iliac artery.¿ post-implantation imaging dated (b)(6) 2021 appears to show: o axial images appear to show a possible infolded proximal device vs.Device in a dissected aorta.(cannot confirm as ¿compression¿ due to not seeing the device in a fully expanded state immediately after implantation.) o there appears to be some areas of occlusion and/or partial occlusion within the implanted device.O there appears to be thrombus within the device limbs.O there appears to be contrast outside the implanted device limbs.O there appears to be narrowing in the device limb that extends into the lci and total occlusion.O there appears to be thrombus within the device limb extending into the rci.O there appears to be dissection in the distal rci or proximal right external iliac artery.The left external iliac artery appears to be occluded to the distal portion of vessel near the left femoral head the review of the manufacturing paperwork verified that this lot met all pre-release specifications; according to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, device occlusion.

Manufacturer Narrative

H1: type of reportable event updated.

• 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: 12823862
• MDR Text Key: 285471832
• Report Number: 3007284313-2021-01662
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622528
• UDI-Public: 00733132622528
• 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: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2023
• Device Model Number: RLT281412
• Device Catalogue Number: RLT281412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male