MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for COVERED CP STENT 427 CVRDCP8Z45 manufactured by Numed, Inc..
[136744571]
The stent was returned in its box, pouch and vial. The covering is completely detached, but is completely intact and undamaged. Four adhesive spots are visible on the covering. A visual examination of the stents shows that the stent was crimped down. The od of the stent is 0. 145". The od of stents is 0. 181" when shipped. The zigs of the complaint stent are also overlapped. The complaint is confirmed, however it appears that the detachment occurred after the stent had been crimped down. A picture is attached that shows the complaint stent next to a stent that was removed from its packaging without being altered. One sample from every lot is tested for adhesion strength of the covering to the stent. The sample from this lot met the acceptance criteria.
Patient Sequence No: 1, Text Type: N, H10
[136744572]
As per the report from the physician / user facility - "after removing the cover stent from the package, it turned out that the eptfe was not attached to stent. The stent was not implanted. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2019-00002 |
| MDR Report Key | 8282442 |
| Date Received | 2019-01-28 |
| Date of Report | 2019-01-28 |
| Date of Event | 2018-11-26 |
| Date Mfgr Received | 2019-01-03 |
| Device Manufacturer Date | 2018-01-30 |
| Date Added to Maude | 2019-01-28 |
| 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 | 2019-01-28 |
| Returned To Mfg | 2019-01-11 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z45 |
| Lot Number | CCP-0854 |
| 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 | 2019-01-28 |