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 2020-03-21 for FLIXENE GRAFT manufactured by Atrium Medical Corporation.
[184423344]
A complete investigation was not able to be performed as no product code, lot number or sample was provided. Per the study, leaving patients with vascular access dysfunction to fate (no intervention) or avf ligation is always simpler and easier. However, it should not be forgotten that paternity for vascular access are limited in these patients. Product not available for return.
Patient Sequence No: 1, Text Type: N, H10
[184423345]
Received an article titled: kahraman, n. E. (2019). Outcomes of arteriovenous fistula reconstruction in vascular access dysfunction. Am j transl res, pp. 1058-1065. Purpose: we investigated avf rescue operations, which we performed for the pathologies causing dysfunctional vascular access, and outcomes of these operations by surgeon-performed preoperative ultrasound (us) in our clinic. Method: 67 patients who were treated in our clinic due to avf dysfunction between january 2012 and january 2016 were included in the study. Per the article adverse events included bleeding and infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2020-00441 |
| MDR Report Key | 9863373 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-21 |
| Date of Report | 2020-03-21 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-21 |
| 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 | 2020-03-21 |
| 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 | 2020-03-21 |