MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-15 for COVERED CP STENT 427 CVRDCP8Z39 manufactured by Numed, Inc..
[62703845]
The detached covering has been confirmed. The covering is undamaged and four glue spots are visible on the covering. The od of the stent is 0. 178". The stents have an od of 0. 181 when shipped from numed. It appears the covering became detached when the physician attempted to remove it from the sheath to re-crimp the stent. A special tool needs to be used to insert the stent through the hemostasis valve, so that the cover will not catch. When pulling back through the hemostasis valve, the covering will catch and detach from the stent. The od of the stent was 0. 178" which is very close to the od of the stent when shipped from numed. It is likely that the stent shifted because it was not fully crimped on the balloon. This indirectly led to the covering issue since it had to be removed back through the hemostasis valve in order to re-crimp the stent on the balloon. The instructions for use states that the stent should be crimped until no movement is felt on the catheter. It also states to place a small amount of undiluted contrast to coat the stent and improve adherence to the balloon. Numed is unable to confirm whether or not this was followed. The distributor has stated that no other information is available.
Patient Sequence No: 1, Text Type: N, H10
[62703846]
As per the report from the distributor: "during delivery, the stent was noticed to be shifted from the balloon. When the physician tried to withdraw the system to reposition the stent, the cover fell off. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2016-00015 |
| MDR Report Key | 6177165 |
| Date Received | 2016-12-15 |
| Date of Report | 2016-12-15 |
| Date of Event | 2016-05-23 |
| Date Mfgr Received | 2016-11-28 |
| Device Manufacturer Date | 2014-01-15 |
| Date Added to Maude | 2016-12-15 |
| 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 | 2016-12-15 |
| Returned To Mfg | 2016-12-01 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z39 |
| Lot Number | CCP-0514 |
| Device Expiration Date | 2019-01-31 |
| 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 | 2016-12-15 |