MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-04-25 for EVOLUTION? COLONIC CONTROLLED-RELEASE STENT - UNCOVERED G48038 EVO-25-30-10-C manufactured by Cook Ireland Ltd.
[143990813]
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
[143990814]
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of? Flexor kinked/ stretched/ broken/ compressed'. User found out the trigger of delivery system cannot release stent any more while the stent has been released 1/3 already. User cannot push the trigger anymore. User retracted the stent into delivery system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001845648-2019-00170 |
| MDR Report Key | 8550055 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-04-25 |
| Date of Report | 2019-05-23 |
| Date of Event | 2019-02-22 |
| Date Facility Aware | 2019-04-23 |
| Date Mfgr Received | 2019-04-02 |
| Device Manufacturer Date | 2018-09-26 |
| Date Added to Maude | 2019-04-25 |
| 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 | 2019-04-25 |
| Returned To Mfg | 2019-05-01 |
| Model Number | G48038 |
| Catalog Number | EVO-25-30-10-C |
| Lot Number | C1543590 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 149 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 | 2019-04-25 |