MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-13 for COVERED CP STENT 427 CVRDCP8Z45 manufactured by Numed, Inc..
[70003035]
The stent was returned bloody and in a (b)(4) bag. Two glue spots are detached, and the covering is torn. The tear starts at one of the glue spots and extends to the middle of the stent. One end of the stent has been crushed until it is almost completely flat. This is the end where the detachment of the covering occurred. It is probably that the covering detached when the stent was crushed during the crimping process. An improper crimping technique was being used. Numed has both mounting videos for physicians showing them the proper technique for crimping the stent, as well as step by step pictorials that are sent with each stent that is not pre-mounted by numed. The mounting process was not followed by the physician.
Patient Sequence No: 1, Text Type: N, H10
[70003036]
As per the report from the foreign distributor: "the customer is complaining that the coating dissolved during crimping. " this means that the covering detached during the crimping process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2017-00008 |
| MDR Report Key | 6399421 |
| Date Received | 2017-03-13 |
| Date of Report | 2017-03-13 |
| Date Mfgr Received | 2017-02-16 |
| Device Manufacturer Date | 2016-05-18 |
| Date Added to Maude | 2017-03-13 |
| 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 | 0 |
| Brand Name | COVERED CP STENT |
| Generic Name | AORTIC STENT |
| Product Code | PNF |
| Date Received | 2017-03-13 |
| Returned To Mfg | 2017-02-22 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z45 |
| Lot Number | CCP-0688 |
| 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 | 2017-03-13 |