MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-09 for COVERED CP STENT 427 CVRDCP8Z39 manufactured by Numed, Inc..
[128032255]
There was no patient contact with this device. The malfunction occurred during the mounting process and did not involve contact with the patient. The stent was returned in a vial.. It stent was clean. The covering is completely detached from the stent. Four glue spots are visible on the covering. The covering is intact and is not damaged. The stent has been crimped. The od of the stent is 0. 160". Stents have an od of 0. 181" when they are shipped from numed. The zigs have not been twisted. The adhesive used on this lot was reviewed and within the expiration date. A sample from every lot of stents is tested for covering adhesion strength as part of the final inspection process. The sample from this lot failed at 4. 31 lbf which is above the acceptance criteria of 1. 5 lbs. The root cause of the detachment cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[128032256]
As reported to numed by the user facility / distributor - cover displaced from cp stent - cp stent was mounted on a dry bib balloon by a long-time numed user. User was cautious to use fresh, dry gloves and to avoid twisting motions during mounting due to past experience and specific instructions from pgm and numed. Despite precautions, the covering still came loose from the stent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2018-00013 |
| MDR Report Key | 8056257 |
| Date Received | 2018-11-09 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-10-08 |
| Date Mfgr Received | 2018-11-15 |
| Device Manufacturer Date | 2014-06-13 |
| Date Added to Maude | 2018-11-09 |
| 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 | 2018-11-09 |
| Returned To Mfg | 2018-10-26 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z39 |
| Lot Number | CCP-0531 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-11-09 |