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.
[179301946]
A complete investigation was not able to be performed as no product code, lot number or sample was provided. Per the study, renal artery restenosis and thrombotic occlusion can result in rapid deterioration of overall kidney function. Timely secondary interventions may restore renal artery patency and recover renal function after occlusion of covered stents placed in renal arteries of patients with fenestrated endografts. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[179301947]
Received an article titled return of baseline kidney function after bilateral renal artery stent occlusion and treatment delay following fenestrated endografting. Purpose: to describe the case of a (b)(6)-year-old woman who underwent fenestrated endovascular aneurysm repair and experienced acute anuric renal failure requiring dialysis secondary to bilateral renal artery stent occlusion for >48 hours. She was successfully treated with revisional endovascular therapy and made a full renal recovery. Method: a case study conclusion: renal artery restenosis and thrombotic occlusion can result in rapid deterioration of overall kidney function. Timely secondary interventions may restore renal artery patency and recover renal function after occlusion of covered stents placed in renal arteries of patients with fenestrated endografts. Per the article adverse events included occlusion, thrombosis and thromboembolic events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2020-00139 |
| MDR Report Key | 9624890 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-23 |
| Date Mfgr Received | 2020-01-20 |
| 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 |