MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-06 for COVERED CP STENT 427 CVRDCP8Z34 manufactured by Numed, Inc..
[64377370]
Device was not returned to numed for evaluation. Very minimal information was received from the foreign distributor and no other information has been received despite numerous requests. Unable to confirm complaint other than the email from the distributor. Distributor did confirm that "dissolved" in their description meant that the covering became detached from the stent. A sample from this lot of stents was tested in final qc for covering strength as per the procedure. The covering pull strength testing for this lot of stents was well above the criteria specified in the procedure.
Patient Sequence No: 1, Text Type: N, H10
[64377371]
As per the email from the foreign distributor: "the coating dissolved during the crimping. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2017-00002 |
| MDR Report Key | 6230076 |
| Date Received | 2017-01-06 |
| Date of Report | 2017-01-06 |
| Date Mfgr Received | 2016-12-16 |
| Device Manufacturer Date | 2014-10-02 |
| Date Added to Maude | 2017-01-06 |
| 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 | 2017-01-06 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z34 |
| Lot Number | CCP-0557 |
| Device Expiration Date | 2019-10-31 |
| 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 | 2017-01-06 |