MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study,use report with the FDA on 2020-03-05 for I-CAST COVERED STENT 85453 manufactured by Atrium Medical Corporation.
[182291229]
On completion of the investigation a follow up report will be submitted. Device evaluated by manufacturer? Not available for return.
Patient Sequence No: 1, Text Type: N, H10
[182291230]
86 days post-procedure the patient was diagnosed with an occlusion of the right renal stent, occlusion or the left renal stent, bilateral renal infarct, and left iliac graft occlusion. Renal occlusions were treated by thrombectomy and additional stent placement. Occlusion in the iliac graft was treated by femoral-femoral bypass.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2020-00366 |
| MDR Report Key | 9796159 |
| Report Source | HEALTH PROFESSIONAL,STUDY,USE |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-07-13 |
| Date Added to Maude | 2020-03-05 |
| 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 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 | I-CAST COVERED STENT |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE |
| Product Code | JCT |
| Date Received | 2020-03-05 |
| Model Number | 85453 |
| Catalog Number | 85453 |
| Lot Number | 448461 |
| 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 | 2020-03-05 |