MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-19 for COVERED CP STENT 427 CVRDCP8Z45 manufactured by Numed, Inc..
[139429267]
The device has not yet returned to numed. The incident report shows that the stent was twisted when it was crimped down onto the balloon catheter. One end of the covering has detached from the stent. Emails from the distributor state that the physician has a problem with crimping the stents, which caused this issue. One sample from every lot of stent is tested for covering strength. The sample that was tested for this lot had a covering attachment strength of 2. 88 lbf, which is above the acceptance criteria. Production records were reviewed and no issues were identified.
Patient Sequence No: 1, Text Type: N, H10
[139429268]
As per the report from the facility/distributor - "the ptfe covering of the stent was not properly attached to the stent. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2019-00006 |
| MDR Report Key | 8433529 |
| Date Received | 2019-03-19 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2019-02-19 |
| Device Manufacturer Date | 2018-10-24 |
| Date Added to Maude | 2019-03-19 |
| 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 | 2019-03-19 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z45 |
| Lot Number | CCP-0947 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-03-19 |