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 2020-01-28 for ICAST COVERED STENT SYSTEM manufactured by Atrium Medical Corporation.
[176685660]
A complete investigation was not able to be performed as no product code, lot number or sample was provided. The article was a clinical presentation of a difficult case. [(b)(4)]. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[176685661]
Received an article titled: hybrid endovascular exclusion of a bleeding innominate artery pseudoaneurysm in a patient with no open surgical options. Purpose: to present the case of a patient who developed a bleeding innominate artery after primary lung cancer resection complicated by an infected chest wound. Method: a case study. Per the article adverse events included blood loss and pseudoaneurysm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2020-00179 |
| MDR Report Key | 9639110 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-01-28 |
| 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 | 2020-01-28 |
| 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 | 2020-01-28 |