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 2019-01-31 for EVOLUTION? COLONIC CONTROLLED-RELEASE STENT - UNCOVERED G48038 EVO-25-30-10-C manufactured by Cook Ireland Ltd.
[134592381]
510(k) number: k163468. (b)(4). The evo-25-30-10-c device of lot number c1526544 was unavailable for evaluation. With the information provided, document based investigation was conducted. This complaint file is dealing with the stent migration. An additional file was opened to deal with the second issue - the yellow marker not being visible. As per customer testimony stent placement was complete prior to removal. Documents review including ifu review: prior to distribution all evo-25-30-10-c devices are subject to visual inspection and functional checks to ensure device integrity. There inspections and functional checks are outlined in internal procedures in place at cirl. A review of the manufacturing records for evo-25-30-10-c device of lot number c1526544 did not reveal any discrepancies that could have contributed to this issue. There is no evidence to suggest that this issue affects the entire lot #c1526544; upon review of complaints this failure mode has not occurred previously with this lot #c1526544. The instructions for use ifu0052-10 which accompanies potential complications: "additional complications include, but are not limited to: stent migration; stent occlusion, ulcerations". There is no evidence to suggest that the customer did not follow the instructions for use ifu0052-10. Root cause review: a definitive root cause could not be determined from the available information. A possible root cause could be attributed to patient anatomy, as per instructions for use, (ifu0052-10), stent migration is listed as a complication following the placement of this device. Summary: complaint is confirmed based on customer's testimony. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. Complaints of this nature will continue to be monitored for potential emerging trends.
Patient Sequence No: 1, Text Type: N, H10
[134592382]
As reported to customer relations: "yellow marker that you should be able to see endoscopically during placement was not moving in coordination with trigger deployment device. They'd never seen that occur before. Couldn't see movement between yellow marker and blue. After placement, stent migrated and then physician removed. Removed complaint device prior to placement and completed procedure with another device successfully".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001845648-2019-00035 |
| MDR Report Key | 8292685 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-03 |
| Date of Event | 2019-01-03 |
| Date Facility Aware | 2019-01-30 |
| Date Mfgr Received | 2019-01-04 |
| Device Manufacturer Date | 2018-08-03 |
| Date Added to Maude | 2019-01-31 |
| 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? COLONIC CONTROLLED-RELEASE STENT - UNCOVERED |
| Generic Name | MQR STENT, COLONIC METALLIC EXPANDABLE |
| Product Code | MQR |
| Date Received | 2019-01-31 |
| Model Number | G48038 |
| Catalog Number | EVO-25-30-10-C |
| Lot Number | C1526544 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 153 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 | 2019-01-31 |