MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for BIFURCATED GORE-TEX? STRETCH VASCULAR GRAFT manufactured by W.l. Gore & Associates.
[185656472]
As the devices were not returned, no evaluation of the devices could be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185656473]
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 4 - the last patient (previously implanted with a bifurcated gore-tex? Stretch vascular graft 20 x 10) presented with an expanding 11. 2-cm symptomatic pgh with vague abdominal pain and was admitted to hospital in preparation for surgical conversion. However, on admission day 3 he suffered a fatal hemorrhagic stroke before the pgh could be resected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00222 |
| MDR Report Key | 9901793 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-05 |
| Date of Event | 2019-10-07 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARCOS AYALA |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL WEST B/P |
| Manufacturer Street | 1505 N. FOURTH STREET |
| Manufacturer City | FLAGSTAFF AZ 86004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 86004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIFURCATED GORE-TEX? STRETCH VASCULAR GRAFT |
| Generic Name | PROSTHESIS, VASCULAR GRAFT |
| Product Code | DSY |
| Date Received | 2020-03-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | FLAGSTAFF AZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Required No Informationntervention | 2020-03-30 |