MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-28 for COVERED STENT ICAST 85453 manufactured by Atrium Medical Corp.
[22152378]
The first icast md attempted to implant malfunctioned. This is the second one opened. It also malfunctioned. This is the second one opened. It also malfunctioned but md was able to "shimmy" the stent back on the balloon and implanted in pt's let renal artery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040548 |
| MDR Report Key | 4479394 |
| Date Received | 2015-01-28 |
| Date of Report | 2015-01-28 |
| Date of Event | 2015-01-26 |
| Date Added to Maude | 2015-02-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COVERED STENT ICAST |
| Generic Name | COVERED STENT ICAST |
| Product Code | NIV |
| Date Received | 2015-01-28 |
| Catalog Number | 85453 |
| Lot Number | 218655131 |
| ID Number | 010065086265634 |
| Device Expiration Date | 2017-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRIUM MEDICAL CORP |
| Manufacturer Address | HUDSON NH 03051 US 03051 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-28 |