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 2020-02-02 for ICAST COVERED STENT SYSTEM manufactured by Atrium Medical Corporation.
[177352741]
A complete investigation was not able to be performed as no product code, lot number or sample was provided. The article concluded that a tailor-made ibd is an easy-to-apply, alternative option for preserving the iia perfusion in short ciaa patients with and without aaa. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[177352742]
Received an article titled technical feasibility and clinical effectiveness of transjugular intrahepatic portosystemic shunt creation in pediatric and adolescent patients. Purpose: to examine the technical feasibility and clinical efficacy of transjugular intrahepatic portosystemic shunt (tips) creation in children and adolescents. Method: 1 icast stent was used in this study. Retrospective review was performed of 59 patients who underwent 61 tips attempts at 3 tertiary children? S hospitals from 2001 to 2017 for acute esophageal or gastroesophageal variceal bleeding, primary and secondary prevention of variceal bleeding, and refractory ascites. Per the article deaths occurred within the study period related to hepatic necrosis, sepsis and hemorrhage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2020-00226 |
| MDR Report Key | 9656991 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-02 |
| Date of Report | 2020-02-02 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-02-02 |
| 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 | 2020-02-02 |
| 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. Life Threatening | 2020-02-02 |