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 CVRDCP8Z45 manufactured by Numed, Inc..
[62844909]
The detachment of the covering has been confirmed. The covering is not damaged and four glue spots are visible on the covering where they were attached. The stent has been slightly flattened and is bent at the second row of welds. The zigs are overlapped, which is a sign of over crimping. It is possible that the hemostasis valve tool did not fully defeat the valve, causing the covering to detach. The mounting procedure included with the instructions for use states: "insert the leading edge of the tool into the hemostasis valve of the sheath. The tool must collapse the entire hemostasis valve to the sides of the introducer to allow the covered stent to pass. " the stent was being used off-label. It is only approved for coarctation of the aorta.
Patient Sequence No: 1, Text Type: N, H10
[62844910]
Per the report from the distributor: "cover fell off when removing the protector sheath. Used 12f protector sheath, 12f cook sheath, 14 x 4. 5 bib. Mounted dry.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2016-00012 |
| MDR Report Key | 6177001 |
| Date Received | 2016-12-15 |
| Date of Report | 2016-12-15 |
| Date of Event | 2016-11-23 |
| Date Mfgr Received | 2016-11-28 |
| Device Manufacturer Date | 2014-01-10 |
| 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 | CVRDCP8Z45 |
| Lot Number | CCP-0515 |
| Device Expiration Date | 2019-01-31 |
| 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 | 2016-12-15 |