MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pseudoaneurysm (2605); No Code Available (3191)

Event Date 10/07/2019

Event Type  Injury  

Manufacturer Narrative

As the devices were not returned, no evaluation of the devices could be performed.(b)(4).

Event Description

The following publication was reviewed: frequency of perigraft hygroma after open aortic reconstruction.The objective of the study was to establish the incidence of and determine the risk factors associated with perigraft hygroma (pgh).Pgh is defined as a perigraft fluid collection of 30mm or greater in diameter with a radiodensity of 30 or fewer hounsfield units on computed tomography at a minimum of 3 postoperative months.Methods and results: patients who underwent open aortic reconstruction for either aneurysmal or occlusive disease between 2004 to 2018 using both eptfe and polyester grafts, and who had follow-up imaging 3 months or more after repair, were included.Of the 140 patients included in the study, 88 were treated with eptfe grafts.It was determined that pgh developed more frequently in patients with eptfe grafts (21/88) compared to those with polyester grafts.Of the 21 patients treated with an eptfe graft and who developed a subsequent pgh, 4 presented with pgh-related symptoms.All pghs developed after abdominal aortic aneurysm repairs.It was hypothesized that intrinsic graft porosity may also contribute to pgh formation.All eptfe grafts were manufactured by w.L.Gore & associates (bifurcated gore-tex® stretch vascular graft).Of the patients treated with an eptfe, 58 were male and 30 were female.The mean age was 68.6 ± 10.2 years.It was concluded that pgh is a complication after open aortic reconstruction for aneurysmal disease, and that patient education and close surveillance is warranted.It was determined that patients who developed pgh had larger aneurysms, more often received eptfe grafts, had larger graft diameters, and had bifurcated grafts.Manufacturer's device modification is deemed necessary.Patient (b)(6) - one patient who had undergone aaa repair in 2004 with a 20x10 eptfe graft was detected to have an asymptomatic 11.0 cm pgh at a 5-year routine follow-up cta.No intervention was planned and the patient was lost to follow-up until 5 years later when he presented with bilateral lower extremity claudication symptoms and underwent bilateral iliac stenting; at that time, a tiny proximal anastomotic pseudoaneurysm was noted.The patient had a follow-up cta 2 years later (12 years after the index operation) and pgh was noted to have increased in size to 13.6 11.8 cm; the pseudoaneurysm was noted to be stable.Conservative therapy was elected and the pseudoaneurysm eventually ruptured into the pgh at 13.6 years.The patient was treated with a resection and partial replacement of the eptfe graft with a polyester graft without recurrence of the pgh.

Manufacturer Narrative

The event involves additional devices reported under mfr report numbers: #2017233-2020-00220 and #2017233-2020-00221.

Manufacturer Narrative

Corrected data: g5.Combination product.

• Brand Name: BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9901089
• MDR Text Key: 196592658
• Report Number: 2017233-2020-00219
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K904282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Treatment: MEDICATION: CREATININE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR