MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-21 for COVERED CP STENT 427 CVRDCP8Z45 manufactured by Numed, Inc..
[70770245]
The stent was implanted in the patient with no issues, and no intervention was required with this patient. Only the covering was returned to numed for evaluation and not the whole device. One stent from every lot is pull tested for covering strength to make sure that the lot meets the required specification of 2lb pull strength. The sample from this lot had a pull strength of over 3 lbs, which is above the specification criteria. Due to the lack of information, numed is unable to determine what happened with this device.
Patient Sequence No: 1, Text Type: N, H10
[70770246]
As per the report from the foreign distributor: "placing covered stent with long sheath (14fr cook/mullins type). Stent was crimped on a 24 x 45 bib, used appropriate insertion tool. After successful placement they took the bib-balloon out of the sheath and at the same time also the complete covering. " patient condition was fine after procedure and no intervention was needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2017-00010 |
| MDR Report Key | 6420588 |
| Date Received | 2017-03-21 |
| Date of Report | 2017-03-21 |
| Date of Event | 2017-02-20 |
| Date Mfgr Received | 2017-02-28 |
| Device Manufacturer Date | 2015-10-02 |
| Date Added to Maude | 2017-03-21 |
| 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 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 | 2017-03-21 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z45 |
| Lot Number | CCP-0638 |
| Operator | PHYSICIAN |
| 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 | 2017-03-21 |