MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-08 for COVERED CP STENT 427 CVRDCP8Z45 manufactured by Numed, Inc..
[67221479]
This device has not been returned to numed for evaluation. From the report given to numed by the user facility, it stated that the physician inserted the device and then removed from the body to reposition. There is a specific warning in the instructions for use that states; " pulling the covered stent back through the introducer and/or hemostasis valve may cause the covering to catch and tear off of the stent. " this is likely what happened in this instance to cause the covering to loosen from the stent.
Patient Sequence No: 1, Text Type: N, H10
[67221480]
As per the report from (b)(6): "physician went into the body with the unmounted stent on a bib balloon, and removed the stent from the body to reposition. It was then noticed that the covering was starting to come off the stent. Physician decided not to re-enter the body with this stent, then opened a pre mounted cp stent in the same size which was deployed without incident. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2017-00004 |
| MDR Report Key | 6311655 |
| Date Received | 2017-02-08 |
| Date of Report | 2017-02-08 |
| Date of Event | 2016-12-27 |
| Date Mfgr Received | 2017-01-18 |
| Device Manufacturer Date | 2016-02-08 |
| Date Added to Maude | 2017-02-08 |
| 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 | 2017-02-08 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z45 |
| Lot Number | CCP-0658 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-02-08 |