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

Catalog Number RLT261414

Device Problem Material Invagination (1336)

Patient Problem No Code Available (3191)

Event Date 09/27/2018

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), complications associated with the use of the gore® excluder® aaa endoprosthesis may include but are not limited to: surgical conversion.The gore® excluder® trunk-ipsilateral leg component rlt261414/17535686 was explanted and discarded at the facility.Therefore, an engineering evaluation could not be performed.

Event Description

The following information was reported to gore: on (b)(6) 2019, this patient underwent endovascular abdominal repair and was treated with gore® excluder® aaa endoprostheses.On an unknown date, the patient returned to the hospital with back pain.On (b)(6) 2018, computed tomography imaging revealed an infolding of the proximal end of the gore® excluder® trunk-ipsilateral leg component rlt261414.The physician was unable to identify a cause as there were no obvious issues relating neither to the device, nor to pre-planning considerations or intra-operative manoeuvers.Reportedly, the patient¿s aortic neck was mildly angulated and showed a slight reverse taper.The condition was stated to have been the only anatomical difficulty.Also on (b)(6) 2018, and as a preventive measure, all gore® excluder® aaa endoprostheses were explanted.The patient tolerated the procedure.

Manufacturer Narrative

Describe event or problem: corrected date of initial implant from (b)(6) 2018.

Event Description

On (b)(6) 2018, this patient underwent endovascular abdominal repair and was treated with gore® excluder® aaa endoprostheses.

• 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: 8425526
• MDR Text Key: 138956815
• Report Number: 3007284313-2019-00075
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622450
• UDI-Public: 00733132622450
• 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: 03/18/2019

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: 12/09/2020
• Device Catalogue Number: RLT261414
• Device Lot Number: 17535686
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 88