MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-01 for COVERED CP STENT 427 CVRDCP8Z45 manufactured by Numed, Inc..
[101633275]
The covered cp stent was returned in a biohazard bag. There is contrast on the stent, so the device was taken out of the packaging and handled in some manner. There is a 1. 5cm tear at one end of the stent. All four glue spots are still attached. The stent was found to be out of round from the handling. The zigs at the end of the stent where the tear occurred are overlapped (refer to pictures). The id of the stent when it returned was 0. 116". The id of the stent when shipped is 0. 141". The complaint is confirmed. It appears that the covering got caught between the overlapped zigs and it likely tore when an attempt was made to remove the covering from between the overlapped zigs. One covered stent is tested from every lot for covering strength. The covering strength from this lot was 2. 13393 lbf, which was above the specification required for release of the lot. In the instructions for use for the covered cp stent, it tells the user when prepping the stent to "avoid unwrapping the folds in the covering. This could cause it to catch and tear off of the stent. " there is also a warning that states "excessive handling and manipulation of the covering while crimping the stent may cause the covering to tear off of the stent. "
Patient Sequence No: 1, Text Type: N, H10
[101633276]
As per the report from (b)(4): "the covering of the cp stent was torn and unusable upon removal from packaging. The stent was not used. The physician was going to use the product for stent placement in rvot prior to tpvr. No crimping was involved. The catheter shaft was not kinked. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2018-00003 |
| MDR Report Key | 7305764 |
| Date Received | 2018-03-01 |
| Date of Report | 2018-03-01 |
| Date of Event | 2018-02-06 |
| Date Mfgr Received | 2018-02-07 |
| Device Manufacturer Date | 2016-03-08 |
| Date Added to Maude | 2018-03-01 |
| 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 | 2018-03-01 |
| Returned To Mfg | 2018-02-26 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z45 |
| Lot Number | CCP-0664 |
| Operator | PHYSICIAN |
| 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 | 2018-03-01 |