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 2020-01-23 for ICAST COVERED STENT SYSTEM manufactured by Atrium Medical Corporation.
[176079485]
A complete investigation was not able to be performed as no product code, lot number or sample was provided. Per the study, these early and intermediate results, which incorporated physician learning curves, support the safety and feasibility of the off-the-shelf zenith p-branch device. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[176079486]
Received an article titled results from a prospective multicenter feasibility study. Purpose: to evaluate the cook zenith p-branch stent graft for the treatment of patients with asymptomatic juxtarenal or pararenal abdominal aortic aneurysms in a prospective nonrandomized, multicenter, feasibility study conducted in the united states. Method: 30 patients were enrolled from january 2013-june 2015. Per the article adverse events included: stent occlusion, renal infarction, renal insufficiency, endoleaks ii and iii, stenosis and claudication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2020-00126 |
| MDR Report Key | 9622508 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-23 |
| Date Mfgr Received | 2020-01-17 |
| Date Added to Maude | 2020-01-23 |
| 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 | MS. LYNDA MCLAUGHLIN |
| 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 | ICAST COVERED STENT SYSTEM |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE |
| Product Code | JCT |
| Date Received | 2020-01-23 |
| 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 | 2020-01-23 |