MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-14 for COVERED CP STENT 427 CVRDCP8Z45 manufactured by Numed, Inc..
[108732507]
The device was returned in a biohazardous condition. Proper precautions were taken in the handling of the device for the evaluation. The stent has been crimped, but was not crimped evenly along the device. Two adhesive spots were detached and two were still attached. All four can be confirmed as having been there. One sample from each lot is tested for covering strength. The sample from this lot met the required pull strength for release of the lot. One end of the covering has been torn and pushed back approximately half the length of the stent. This is seen when the device is inserted into a hemostasis valve of an introducer without the use of the hemostasis tools provided with the covered stent. The device is shipped with both an instructions for use that states the necessary steps for inserting into the hemostasis valve as well as an ifu insert that provides written as well as a pictorial presentation of the steps for mounting and inserting the covered stent. These instructions were not followed in this case. The tearing of the covering was due to user handling as well as failure to follow instructions. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[108732508]
As per the report from the hospital and distributor - "the covered layer torn mounting the stent on the balloon. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2018-00006 |
| MDR Report Key | 7511464 |
| Date Received | 2018-05-14 |
| Date of Report | 2018-05-14 |
| Date of Event | 2018-04-13 |
| Date Mfgr Received | 2018-04-26 |
| Device Manufacturer Date | 2017-01-12 |
| Date Added to Maude | 2018-05-14 |
| 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 | 2018-05-14 |
| Returned To Mfg | 2018-05-08 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z45 |
| Lot Number | CCP-0752 |
| 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 | 2018-05-14 |