MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-31 for COVERED CP STENT 427 CVRDCP8Z45 manufactured by Numed, Inc..
[109898350]
The device was returned for evaluation. The covering is completely in tact with no issues. All four glue spots are attached and there was nothing wrong with it. The distal end of the stent had one zig that was bent out (see attached pictures - 835 complaint stent and 835 complaint stent2). Numed pulled a comparative stent to try and similate the bend in the zig like the complaint stent. When sliding the stent on a balloon catheter, when the balloon did not have a vacuum on it, the stent caught on the balloon during the advancement and ended up with similar damage to one of the zigs (see attached pictures - 835 comparative1 and 835 comparative2). Numed fully inspects all zigs on each stent before it is placed in a bottle for packaging. The bent zig had to had occurred at the user facility. Similar damage was observed while forcing a stent over a balloon that had not been properly prepped, making improper handling the most likely cause of the complaint. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[109898371]
As received by the distributor in turkey - "before the coarctation of the aorta case of the patient, the covered cp stent was checked and it was observed that the proximal of the distal ends of the stent were deformed and there were defects on the covered parts of the stent. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2018-00007 |
| MDR Report Key | 7557760 |
| Date Received | 2018-05-31 |
| Date of Report | 2018-05-31 |
| Date of Event | 2018-05-07 |
| Date Mfgr Received | 2018-05-09 |
| Device Manufacturer Date | 2017-11-20 |
| Date Added to Maude | 2018-05-31 |
| 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 | 2018-05-31 |
| Returned To Mfg | 2018-05-17 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z45 |
| Lot Number | CCP-0824 |
| 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 | 2018-05-31 |