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 2020-01-15 for I-CAST COVERED STENT SYSTEM 85453 manufactured by Atrium Medical Corporation.
[175046924]
On completion of the investigation a follow up report will be submitted. Not available for return.
Patient Sequence No: 1, Text Type: N, H10
[175046925]
It was reported that the day following observation of the right renal stent occlusion, the patient was treated by performing a thrombectomy and placement of a vbx stent into the right renal artery over the previously placed icast stent.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3011175548-2020-00060 |
MDR Report Key | 9591060 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-01-15 |
Date of Report | 2020-01-15 |
Date of Event | 2020-01-06 |
Date Mfgr Received | 2020-02-18 |
Device Manufacturer Date | 2019-06-21 |
Date Added to Maude | 2020-01-15 |
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 | I-CAST COVERED STENT SYSTEM |
Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE |
Product Code | JCT |
Date Received | 2020-01-15 |
Model Number | 85453 |
Catalog Number | 85453 |
Lot Number | 448077 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
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 | 2020-01-15 |