MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for FLIXENE GRAFT manufactured by Atrium Medical Corporation.
[186750854]
A complete investigation was not able to be performed as no product code, lot number or sample was provided. Per the study, iaavgs allow earlier cannulation and tunneled catheter removal, thereby significantly decreasing catheter related complications. Product not available for return.
Patient Sequence No: 1, Text Type: N, H10
[186750855]
Received an article titled: dillavou, e. E. (2019). Immediate access arteriovenous grafts decrease catheter days and complications. Vascular access, p. E332. Purpose: this study compares iaavg to standard arteriovenous grafts (savg) as well as describing iaavg use with hero outflow. Method: all patients who underwent placement of av graft from 1/2014 - 4/2016 at two large tertiary referral centers were retrospectively identified in the electronic medical record and through the vascular quality initiative (vqi). Per the article adverse events included occlusion, steal syndrome and graft infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2020-00438 |
| MDR Report Key | 9861713 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-20 |
| 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 Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal | 03054 |
| Manufacturer G1 | ATRIUM MEDICAL CORPORATION |
| Manufacturer Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLIXENE GRAFT |
| Generic Name | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
| Product Code | DSY |
| Date Received | 2020-03-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRIUM MEDICAL CORPORATION |
| Manufacturer Address | 40 CONTINENTAL BLVD MERRIMACK NH 03054 US 03054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-20 |