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 2019-05-30 for EVOLUTION? COLONIC CONTROLLED-RELEASE STENT - UNCOVERED EVO-25-30-6-C manufactured by Cook Ireland Ltd.
[146515067]
510(k) number: k163468. (b)(4). The evo-25-30-6-c device of unknown lot number device involved in this complaint was not returned to cook ireland for evaluation. With the information provided, document based investigation was conducted. A review of the manufacturing records could not be performed as the lot numbers for the devices used are unknown. Prior to distribution all evo devices are subjected to visual and functional inspection checks to ensure device integrity as per cook irl procedures. There is also a 100% visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc. The instructions for use, ifu0052-10, that accompanies this device instructs the user to inspect the device prior to use : "if an abnormality is detected that would prohibit proper working condition, do not use". There is evidence to suggest that the customer did not follow the instructions for use ( ifu0052-10). A definitive root cause can be attributed to user error as evo devices should not be used beyond the date specified on the product label, therefore the user did not follow the instructions for use. The customer complaint can be confirmed as the device was used after its expiry date. From the information provided, "the patient is doing well, for someone who has terminal cancer. There were no other issues, just the fact that the stent placed is expired. " (ref. Att. 're pr262346 complaint form for completion'). Complaints of this nature will continue to be monitored for potential emerging trends.
Patient Sequence No: 1, Text Type: N, H10
[146515068]
As reported to customer relations, "this was simply an expired sems stent placement, the staff and dr. Did not check the expiration date and the stent was placed successfully. The stent expired in (b)(6) 2019".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001845648-2019-00231 |
| MDR Report Key | 8652938 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-04-30 |
| Date Facility Aware | 2019-05-01 |
| Date Mfgr Received | 2019-05-02 |
| Date Added to Maude | 2019-05-30 |
| 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 | 2019-05-30 |
| Catalog Number | EVO-25-30-6-C |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-05-30 |