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

Catalog Number PXC141200J

Device Problem Unintended Movement (3026)

Patient Problem Aneurysm (1708)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

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 with may occur and/or require intervention including, but not limited to, endoleak.

Event Description

Following was reported to gore.On (b)(6) 2016, a patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.On an unknown date, follow up imaging revealed a type ii endoleak from the inferior mesenteric artery (ima), but no aneurysm enlargement was observed; hence it was monitored.In (b)(6) 2020, follow up imaging revealed a continuous type ii endoleak and more than 5mm aneurysm enlargement.Additionally, a type iii endoleak (component disconnection) between contralateral leg components (pxc141200j and pxc141400j) that was placed on the left side was suspected.On (b)(6) 2020, a reintervention was performed.An additional stent graft was placed for treatment of the type iii endoleak, and coil embolization of the ima was performed.During the reintervention, there was no distal type i endoleak but an additional stent graft was placed prophylactically at the right side.The patient tolerated the procedure.

Manufacturer Narrative

B3: date of event - corrected to (b)(6) 2020.The actual date of the event is unknown, but reintervention occurred at some time in that month, so this has been chosen as the date of event.H10/11: narrative/corrected data -additional device involved in this event: pxc141400j, lot number 14510162, udi (b)(4), (b)(4), (b)(4).

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10214797
• MDR Text Key: 201204386
• Report Number: 2953161-2020-00023
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: PXC141200J
• Device Lot Number: 14380196
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR