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 2019-04-15 for EVOLUTION? DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED G48027 EVO-22-27-12-D manufactured by Cook Ireland Ltd.
[142274567]
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
[142274568]
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?. As initially reported to customer relations: a patient of unknown age and gender underwent an upper endoscopy with placement of duodenal stent which the evolution duodenal controlled-release stent, g48027- qty. 2 were used. (an additional file was created to capture the second device) both stents were prepped correctly. Both were passed down the scope. When asked to deploy, the trigger was squeezed and the little plastic piece moved down the handle, but the catheter did not move and the stent did not deploy. There was an audible click with the second stent. The position was good and scope was straight inside. Dr. Reported the scope was not looped tight on the outside. This is the message that was sent to me [district manager] from the nurse. The reference to the little plastic piece on the handle is the indicator for where they are in the deployment. The procedure was completed by using a third stent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001845648-2019-00144 |
| MDR Report Key | 8514438 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-15 |
| Date of Report | 2019-05-13 |
| Date of Event | 2019-03-18 |
| Date Facility Aware | 2019-03-19 |
| Date Mfgr Received | 2019-03-20 |
| Device Manufacturer Date | 2018-09-06 |
| Date Added to Maude | 2019-04-15 |
| 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. 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 | 2019-04-15 |
| Returned To Mfg | 2019-04-16 |
| Model Number | G48027 |
| Catalog Number | EVO-22-27-12-D |
| Lot Number | C1537320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 193 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 | 2019-04-15 |