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 2020-02-25 for STENTS I-CAST 85415 manufactured by Atrium Medical Corporation.
[184259310]
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[184259311]
During a complicated aaa case while using two 7x59 stents one of the balloons only opened at the distal end. After multiple attempts to expand balloon the doctor was able to release the balloon and remove it from the partially deployed stent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2020-00322 |
| MDR Report Key | 9752469 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-02-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | STENTS I-CAST |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE |
| Product Code | JCT |
| Date Received | 2020-02-25 |
| Model Number | 85415 |
| Catalog Number | 85415 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-02-25 |