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

Catalog Number RLT231412

Device Problem Collapse (1099)

Patient Problem Occlusion (1984)

Event Date 09/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The following was reported to gore: on (b)(6) 2019, the patient presented with an abdominal aortic aneurysm that was successfully treated with gore® excluder® aaa endoprostheses.On (b)(6) 2019, the patient presented with pain in the abdominal region and it was realized that the gore® excluder® trunk-ipsilateral leg endoprosthesis (rlt) had collapsed.On (b)(6) 2019, the right leg of the rlt was recanalized and a thrombectomy was performed.The collapsed rlt was reopened with the implantation of a gore® excluder® aaa aortic extender endoprosthesis.The patient tolerated the procedure.Additional it was stated that it is unknown what caused or could have caused the collapse of the device.The patient was treated according to the gore® excluder® aaa endoprosthesis instructions for use (ifu) and it was stated that no anatomical characteristics or calcification/thrombus in the aortic neck contributed to the incident.

Manufacturer Narrative

Engineering evalaution: the device evaluation was performed based on what was reported to gore as the device was not returned for analysis.Without a physical sample to evaluate, the physician¿s observation that the trunk-ipsilateral leg endoprosthesis had collapsed cannot be conclusively confirmed.The likely cause for the apparent reported collapsed trunk-ipsilateral leg endoprosthesis could not be determined from the information provided.

• 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
• MDR Report Key: 9213362
• MDR Text Key: 163042084
• Report Number: 3007284313-2019-00317
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622368
• UDI-Public: 00733132622368
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

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: 04/06/2022
• Device Catalogue Number: RLT231412
• Device Lot Number: 20442308
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR