MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-18 for COVERED CP STENT 427 CVRDCP8Z45 manufactured by Numed, Inc..
[106043862]
The covered stent was returned and the stent is clean. Two adhesive spots are detached, otherwise the covering is undamaged. Four adhesive spots are visible on the covering. The stent has been crimped down. The zigs are twisted at the end of the stent where the detachment occurred. The zigs at this end of the stent are overlapped. The outer layer of glue for each of the detached adhesive spots is intact and attached to the covering. The detachment is confirmed. The zigs at the end of the stent were twisted and overlapped, which damaged the inner layer of glue for each of the detached adhesive spots, allowing the detachment to occur. This damage was caused by user handling during the crimping process. A sample from each lot of stents is tested for covering strength. The sample met the required testing strength for release of the lot.
Patient Sequence No: 1, Text Type: N, H10
[106043863]
Covering became dislodged during mounting process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2018-00004 |
| MDR Report Key | 7439365 |
| Date Received | 2018-04-18 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-03-21 |
| Date Mfgr Received | 2018-03-27 |
| Device Manufacturer Date | 2017-04-25 |
| Date Added to Maude | 2018-04-18 |
| 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. NICHELLE LAFLESH |
| Manufacturer Street | 2880 MAIN STREET |
| Manufacturer City | HOPKINTON NY 12965 |
| Manufacturer Country | US |
| Manufacturer Postal | 12965 |
| Manufacturer Phone | 3153284491 |
| Manufacturer G1 | NUMED, INC. |
| Manufacturer Street | 2880 MAIN STREET |
| Manufacturer City | HOPKINTON NY 12965 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12965 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COVERED CP STENT |
| Generic Name | AORTIC STENT |
| Product Code | PNF |
| Date Received | 2018-04-18 |
| Returned To Mfg | 2018-04-17 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z45 |
| Lot Number | CCP-0780 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUMED, INC. |
| Manufacturer Address | 2880 MAIN STREET HOPKINTON NY 12965 US 12965 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-18 |