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 CVRDCP8Z28 manufactured by Numed, Inc..
[62849846]
The detachment of the covering has been confirmed. The covering was undamaged, but returned bloody. All four glue spots were confirmed. There was minimal information available for this complaint. The distributor stated that they are unable to get more information. The stent has been flattened and the zigs are overlapped. It is unknown if the hemostasis valve tools were used for the introduction of the covered cp stent into the hemostasis valve of the introducer. The mounting procedure provided with the instructions for use specifically states that these tools are to be used for inserting the covered cp stent into the hemostasis valve of the introducer. It is likely that these tools were not used, but numed is unable to confirm this.
Patient Sequence No: 1, Text Type: N, H10
[62849847]
As per the report from the distributor: "cover fell off when passing the hemstatic valve on the cook sheath. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2016-00013 |
| MDR Report Key | 6177055 |
| Date Received | 2016-12-15 |
| Date of Report | 2016-12-15 |
| Date of Event | 2016-10-13 |
| Date Mfgr Received | 2016-11-28 |
| Device Manufacturer Date | 2016-05-18 |
| 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 | CVRDCP8Z28 |
| Lot Number | CCP-0686 |
| 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 |