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 2019-01-10 for EVOLUTION? DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED G48025 EVO-22-27-6-D manufactured by Cook Ireland Ltd.
[132789432]
510 (k) number; k163468. (b)(4). Information pertaining to section as follows: importer site contact and address: (b)(4). Importer site establishment registration number: (b)(4). Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
Patient Sequence No: 1, Text Type: N, H10
[132789433]
During deployment, the yellow marker was in view and upon 50% deployment, the user pulled the safety wire but it was extremely difficulty to remove. The wire was removed with force, and the stent deployed significantly past the intended target site. Another stent is scheduled to be placed on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001845648-2019-00011 |
| MDR Report Key | 8235795 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-10 |
| Date of Report | 2019-01-10 |
| Date of Event | 2018-12-13 |
| Date Facility Aware | 2018-12-13 |
| Date Mfgr Received | 2018-12-13 |
| Device Manufacturer Date | 2018-10-04 |
| Date Added to Maude | 2019-01-10 |
| 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. HEATHER RYAN |
| Manufacturer Street | O HALLORAN ROAD NATIONAL TECHNOLOGY PARK |
| Manufacturer City | LIMERICK |
| Manufacturer Phone | 061334440 |
| Manufacturer G1 | COOK IRELAND LTD |
| Manufacturer Street | O HALLORAN ROAD NATIONAL TECHNOLOGY PARK |
| Manufacturer City | LIMERICK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVOLUTION? DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED |
| Generic Name | MUM STENT, METALIC EXPANDABLE, DUODENAL |
| Product Code | MUM |
| Date Received | 2019-01-10 |
| Model Number | G48025 |
| Catalog Number | EVO-22-27-6-D |
| Lot Number | C1546233 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 50 DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK IRELAND LTD |
| Manufacturer Address | O HALLORAN ROAD LIMERICK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-10 |