MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-18 for COVERED CP STENT 427 CVRDCP8Z34 manufactured by Numed, Inc..
[83311170]
The covering detachment is confirmed. The stent has been crimped down, even though the report states that this happened prior to crimping. The od of the stet is 0. 150". The stents are shipped with an od of 0. 181". Sever overlapping of the zigs at the ends of the stent were observed (see attached photos). One of the zigs has been manipulated in a way that left it completely turned over. Upon examination of the stent it has been determined that the detachment was most likely caused by mishandling of the stent either during crimping or before crimping. The od of the returned stent was well below the od of stents when they are shipped. The ends of the stent were overlapped and deformed. All covered stents are inspected in final qc to insure each covering has (4) acceptable glue spots. The stent are visually inspected once more after they are packaged for covering adhesion. A sample from each lot is tested for covering strength. The sample from this lot failed at 2. 82lbs, well above the 1. 5lb minimum.
Patient Sequence No: 1, Text Type: N, H10
[83311171]
As per the incident report from the distributor - "covering material outside cp stent was damaged prior to crimping hence was not used for deployment. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2017-00023 |
| MDR Report Key | 6803436 |
| Date Received | 2017-08-18 |
| Date of Report | 2017-08-18 |
| Date of Event | 2017-07-31 |
| Date Mfgr Received | 2017-08-02 |
| Device Manufacturer Date | 2015-06-11 |
| Date Added to Maude | 2017-08-18 |
| 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 | 2017-08-18 |
| Returned To Mfg | 2017-08-15 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z34 |
| Lot Number | CCP-0597 |
| 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 | 2017-08-18 |