MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-20 for FLIXENE GRAFT manufactured by Atrium Medical Corporation.
[188982751]
A complete investigation was not able to be performed as no product code, lot number or sample was provided. Per the study, despite the invasiveness, direct atrial outflow procedures remain a valid alternative in carefully selected patients with adequate cardiopulmonary reserve. Product not available for return.
Patient Sequence No: 1, Text Type: N, H10
[188982752]
Received an article titled: lopez-pena, g. E. (2019). Comparison of axillary-atrial and axillary-iliac arteriovenous grafts for hemodialysis access creation. The journal of vascular access, pp. 55-59. Purpose: the aim of this study was to compare two complex vascular access techniques that utilize the axillary artery as inflow and accesses were created with early cannulation grafts: the axillary-atrial arteriovenous graft versus axillary-iliac arteriovenous graft. Method: this is a retrospective study of end-stage renal disease patients with occluded intrathoracic central veins that underwent complex hemodialysis access creation in our institution after failed endovascular recanalization attempts. Per the article adverse events included pseudoaneurysm, thromboembolic events, restenosis and infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2020-00439 |
| MDR Report Key | 9861716 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| 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 |