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 2018-09-20 for EVOLUTION? DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED EVO-22-27-6-D manufactured by Cook Ireland Ltd.
[120829448]
The 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
[120829449]
Per complaint form: dr. (b)(6) placed an evolution duodenal stent in a stricture in the duodenal bulb of the patient. Six week post, he went back in and found the metal stent somewhat collapsed and floating in the bulb. He said when placed it was 6cm, when he pulled it out it had collapsed to 1cm. He said it seemed like it might have been defective. The stent was removed from the body after it was found floating in the duodenal bulb six weeks post procedure. There was no patient issues, he just had to place another stent. Also, in same area he had also placed a wallmax stent, that stent had no issues and is still in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001845648-2018-00439 |
| MDR Report Key | 7893056 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-20 |
| Date of Report | 2018-10-18 |
| Date of Event | 2018-08-23 |
| Date Facility Aware | 2018-11-15 |
| Date Mfgr Received | 2018-08-28 |
| Date Added to Maude | 2018-09-20 |
| 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 | 2018-09-20 |
| Catalog Number | EVO-22-27-6-D |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 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 | 2018-09-20 |