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 2019-01-16 for EVOLUTION? COLONIC CONTROLLED-RELEASE STENT - UNCOVERED G48028 EVO-25-30-8-C manufactured by Cook Ireland Ltd.
[133220464]
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
[133220465]
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'. "impossible to deploy stent". Rep will arrange return. "as per complaint form": stent would not deploy. Additional information received 19-dec-18: was the directional button fully engaged? Yes. Did the red indicator move when the trigger was pressed? Yes. Did the red indicator continue to move after the delivery stopped? Yes. Were any cracking/popping sounds heard from the handle? Not known. Was the stent partially exposed? No. If the stent was partially exposed, was it possible to recapture the stent fully before removal? Na. Were any additional procedures needed? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001845648-2019-00021 |
| MDR Report Key | 8252017 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-16 |
| Date of Report | 2019-02-13 |
| Date of Event | 2018-12-12 |
| Date Facility Aware | 2019-01-16 |
| Date Mfgr Received | 2018-12-12 |
| Device Manufacturer Date | 2017-01-06 |
| Date Added to Maude | 2019-01-16 |
| 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 | 2019-01-16 |
| Returned To Mfg | 2019-01-29 |
| Model Number | G48028 |
| Catalog Number | EVO-25-30-8-C |
| Lot Number | C1311877 |
| Device Expiration Date | 2019-01-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 705 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 | 2019-01-16 |