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.
[177334559]
A complete investigation was not able to be performed as no product code, lot number or sample was provided. The article concluded endovascular repair is effective with an acceptable safety profile in the treatment of nco and postsurgical complications of coarctation after initial osr. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[177334560]
Received an article titled multicenter experience with endovascular treatment of aortic coarctation in adults. Purpose: the objective of this study was to evaluate outcomes of endovascular treatment of aortic coarctation in adults. Method: clinical data and imaging studies of 93 consecutive patients treated at nine institutions from 1999 to 2015 were reviewed. Per the article deaths occurred within the study period.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2020-00211 |
| MDR Report Key | 9656983 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-02 |
| Date of Report | 2020-02-02 |
| Date Mfgr Received | 2020-01-23 |
| 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 |