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

Catalog Number RLT311415J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Aortic Dissection (2491)

Event Date 09/04/2020

Event Type  malfunction  

Event Description

(b)(4) gore reported the following: on (b)(6) 2020, the patient underwent endovascular treatment of an abdominal aortic aneurysm and dissection using gore® excluder® aaa endoprostheses.After the trunk-ipsilateral leg (rlt311415j/21791597) was implanted, when the physician attempted to withdraw the delivery catheter, it was confirmed that the leading olive was disengaged and found in the valve of the dryseal flex introducer sheath.The disengaged olive and catheter was retrieved and no adverse event occurred on the patient.The physician commented that no resistance was felt when he withdrew the delivery catheter.It was reported dryseal valve was pressurized with 1.5cc of saline.

Manufacturer Narrative

Addition h6: code 213-the review of the manufacturing paperwork verified that this lot met all pre-release specifications.Addition the device was returned to gore for evaluation.The device evaluation showed the leading end is detached from the rest of the device.The polyimide length of the detached section is approximately 8cm from the base of the olive and detached at the mid olive.The olive is still attached to the delivery system and appears to be intact with no visible defects.The severed end of the polyimide was visually inspected.The polyimide appears to have been fractured.The other end of the fractured polyimide can be observed at the mid-olive transition.Based on the findings from this evaluation, the physician¿s observation that the leading olive was disengaged, was confirmed.The separation appears to be a fracture of the polyimide at the mid-olive transition of the catheter.The likely cause for the fractured guidewire polyimide lumen could not be determined with the available information.

• 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
• MDR Report Key: 10532518
• MDR Text Key: 209593809
• Report Number: 3007284313-2020-01063
• Device Sequence Number: 1
• Product Code: MIH
• 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: 01/29/2021

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: 03/04/2023
• Device Catalogue Number: RLT311415J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 01/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR