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 Pain (1994); No Code Available (3191)

Event Date 10/07/2019

Event Type  Injury  

Manufacturer Narrative

(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 gore® surgical 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.The following corrections to the article were reported by the corresponding author: there were 18 asymptomatic patients (not 17), none of whom underwent an intervention.There were 22 patients who developed pgh after being treated with a gore® device (not 21).All eptfe grafts were manufactured by w.L.Gore & associates (bifurcated gore-tex® stretch vascular graft).Of the patients treated with a gore® device, 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 3- another patient (previously implanted with bifurcated gore-tex® stretch vascular graft 18 x 9) presented with an 11.0-cm sac with compression symptoms.Aspiration of periaortic fluid was performed at 33 months.The pgh however, recurred, measuring 14 cm at 59 months accompanied by vague abdominal pain.While the patient was awaiting open surgical revision, the pgh expanded rapidly to 18 cm and ruptured into the inferior vena cava.He underwent emergent partial explantation of the eptfe graft and replacement with a bifurcated polyester graft.The patient was allowed to recover and underwent relining of the distal remnants of the eptfe graft with gore iliac extender graft 6 weeks later.

Manufacturer Narrative

The event involves additional devices reported under mfr report numbers: #2017233-2020-00219 and #2017233-2020-00220.

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: 9901727
• MDR Text Key: 194119215
• Report Number: 2017233-2020-00221
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/10/2020; 07/09/2020
• 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