MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-18 for COVERED CP STENT 427 CVRDCP8Z45 manufactured by Numed, Inc..
[83279829]
The covering detachment was confirmed. Four adhesive spots are visible on the stent. One end of the stent has been crimped down. The root cause of this complaint cannot be determined. All covered stents are inspected in final qc to make sure that each covering has (4) acceptable glue spots. The stents are visually inspected once more after they are packaged for covering adhesion. A sample from each lot is tested for covering strength. The sample from this lot failed at 2. 95 lbs, which is well above the 1. 5 lb minimum required.
Patient Sequence No: 1, Text Type: N, H10
[83279830]
(b)(4) - "intervention planned in aortic re-coarctation. Six (6) years prior treatment with stent palmaz. Failure happened during crimping of the stent on bib, the teflon came loose, thus the stent was not used. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2017-00022 |
| MDR Report Key | 6803422 |
| Date Received | 2017-08-18 |
| Date of Report | 2017-08-18 |
| Date of Event | 2016-09-11 |
| Date Mfgr Received | 2017-07-26 |
| Device Manufacturer Date | 2015-05-05 |
| Date Added to Maude | 2017-08-18 |
| 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 | 2017-08-18 |
| Returned To Mfg | 2017-08-08 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z45 |
| Lot Number | CCP-0586 |
| 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 | 2017-08-18 |