MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-01 for COVERED CP STENT 427 CVRDCP8Z45 manufactured by Numed, Inc..
[76728571]
The stent was returned in the bottle, pouches and box. The stent and covering are clean. The covering is completely detached. There are four (4) adhesive spots on the covering. The covering is not damaged and the folds are still present. The stent has been crimped down. The od of the stent measures 0. 150" and the zigs at each end of the stent are severly overlapped. Upon product release at numed, the stent od measures 0. 181". Detachment is confirmed. It is probable that the overlapped zigs caused the adhesive spots to come loose. An improper crimping technique was being used. Numed has both mounting videos for physicians showing them the proper technique for crimping the stent, as well as step by step pictorials that are sent with each stent that is not pre-mounted. The mounting process was not followed by the physician. Sample from each lot is tested for covering pull strength. This sample met the acceptance criteria of a minimum of 1. 5 lbf. This sample had a pull strength of 2. 45 lbf.
Patient Sequence No: 1, Text Type: N, H10
[76728572]
As per report by foreign user facility: "the covering has come off. Failure detected before application. No impact on patient, user or third person. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2017-00015 |
| MDR Report Key | 6604968 |
| Date Received | 2017-06-01 |
| Date of Report | 2017-06-01 |
| Date Mfgr Received | 2017-05-04 |
| Device Manufacturer Date | 2015-03-09 |
| Date Added to Maude | 2017-06-01 |
| 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. MELISSA THOMAS |
| 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 | 2017-06-01 |
| Returned To Mfg | 2017-05-26 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z45 |
| Lot Number | CCP-0581 |
| 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 | 2017-06-01 |