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 2019-05-03 for EVOLUTION? COLONIC CONTROLLED-RELEASE STENT - UNCOVERED G48038 EVO-25-30-10-C manufactured by Cook Ireland Ltd.
[143949768]
510(k) number: k163468. (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
[143949769]
User advanced the delivery system through wire guide to desired stenosis area. User placed the delivery system at 3-4cm front of stenosis area and ready to release the stent. User pulled the trigger each time and the sheath backed a little, and meanwhile the yellow marker on the stent always stays at 3-4 cm front of stenosis. User saw the tip of the stent open through x-ray, but the stent suddenly move forward and detached from sheath while user release the stent in half. The yellow marker on the tip of stent still remains at 3-4cm front of stenosis, user cannot retract the stent by pressing the retracting trigger. User saw the whole stent squeeze in 4cm long 4cm in front of stenosis area. User left the stent in patient colon and placed another stent at stenosis area with no issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001845648-2019-00191 |
| MDR Report Key | 8577446 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-31 |
| Date of Event | 2019-03-04 |
| Date Facility Aware | 2019-05-03 |
| Date Mfgr Received | 2019-04-09 |
| Device Manufacturer Date | 2018-11-09 |
| Date Added to Maude | 2019-05-03 |
| 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. 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? COLONIC CONTROLLED-RELEASE STENT - UNCOVERED |
| Generic Name | MQR STENT, COLONIC METALLIC EXPANDABLE |
| Product Code | MQR |
| Date Received | 2019-05-03 |
| Returned To Mfg | 2019-05-01 |
| Model Number | G48038 |
| Catalog Number | EVO-25-30-10-C |
| Lot Number | C1556613 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 115 DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-03 |