MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-20 for COVERED CP STENT 427 CVRDCP8Z39 manufactured by Numed, Inc..
[128265659]
The covered cp stent was placed in the patient in (b)(6) 2007; 11 years later the patient developed recoarctation of the aorta and underwent placement of a second cp stent. It was during this placement that it was noticed that the original covered cp stent had fractured. A review of the pictures and film that was sent to numed confirmed the fractures of the device. All pieces are accounted for on the cp stent. None of the pieces or wires had detached completely from the stent. Stent fracture is a known risk with this type of device. There were (15) stents manufactured in this lot. There have been no other fractures reported for this lot of covered cp stents. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[128265660]
Numed received an email stating that a patient in (b)(6) came in for a second cp stent for recoarctation of the aorta. During the placement of the second cp stent, it was noticed that the original covered cp stent had fractured. The original covered cp stent was placed in this patient in (b)(6) 2007.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2018-00016 |
| MDR Report Key | 8090910 |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-20 |
| Date Mfgr Received | 2018-11-09 |
| Device Manufacturer Date | 2007-08-20 |
| Date Added to Maude | 2018-11-20 |
| 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 | 2018-11-20 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z39 |
| Lot Number | CCP-0221 |
| Device Expiration Date | 2012-08-31 |
| 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 | 2018-11-20 |