MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-12-13 for CP STENT 425 CP8Z22 manufactured by Numed, Inc..
[130259871]
The device has not yet been returned to numed for evaluation. If the device is returned and anything is found that will affect or change this report, a follow-up mdr report will be sent. The device was being used off-label. This device is only approved for use in coarctation of the aorta. They physician was using this device for lpa stenting, which is an off-label use. Stent migration is a known potential complication for stents and is listed in the instructions for use.
Patient Sequence No: 1, Text Type: N, H10
[130259872]
As per the report from the foreign manufacturer and physician - "after deployment, lpa stent embolized to mpa upon removal of wire. Attempts to redeploy it in lpa or rpa failed. The stent was then snared out".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2018-00017 |
| MDR Report Key | 8161187 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-12-13 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2018-11-27 |
| Device Manufacturer Date | 2016-04-25 |
| Date Added to Maude | 2018-12-13 |
| 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 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 | 3 |
| Brand Name | CP STENT |
| Generic Name | AORTIC STENT |
| Product Code | PNF |
| Date Received | 2018-12-13 |
| Returned To Mfg | 2019-01-10 |
| Model Number | 425 |
| Catalog Number | CP8Z22 |
| Lot Number | CP-0757 |
| Device Availability | R |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2018-12-13 |