MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-17 for I-CAST COVERED STENT 85453 manufactured by Atrium Medical Corporation.
[186839898]
On completion of the investigation a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[186839899]
It was reported that a patient had 2 stents placed in the right renal artery. A type iii endoleak was noted right after the stents were placed. The intervention was successful and the leak was resolved. Blood loss was 200 ml.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2020-00418 |
| MDR Report Key | 9845854 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2018-06-04 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2017-05-15 |
| Date Added to Maude | 2020-03-17 |
| 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 | I-CAST COVERED STENT |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE |
| Product Code | JCT |
| Date Received | 2020-03-17 |
| Model Number | 85453 |
| Catalog Number | 85453 |
| Lot Number | 415013 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2020-03-17 |