MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for CP STENT 425 CP8Z39 manufactured by Numed, Inc..
[136610435]
The complaint stent was returned in its box and outer pouch. There is no blood on the stent and there is no evidence that the stent entered the body. The stent is deformed and appears to have been partially expanded. The length of the stent is approximately 3. 7 cm. The foreshortening chart in the ifu shows that an 8 zig, 3. 9 cm cp stent would have to be inflated to 12 or 14mm to reach this length. It is impossible to determine when, where, how or why they stent slipped off of the bib without more information, however, it is likely that the dislodgement was caused by one of the following: the hemostasis valve tool was not used to properly defeat the hemostasis valve in the introducer, or the stent was not securely crimped down on the balloon. The following statements are in the instructions for use - "gently crimp (see insert ifu-cpce) the stent on the balloon by using finger pressure and a "rolling action" to exert equal pressure on all sides of the stent. Only crimp until no movement is felt on the catheter. Platinum is very malleable and should be easily crimped. Place a small amount of undiluted contrast to "coat" the stent and improve adherence to the balloon. (avoid bending or twisting the stent). " the ifu-cpce (mounting instructions sent with the instructions for use) also contains information about the use of the hemostasis valve tools to defeat the hemostasis valve on the introducer.
Patient Sequence No: 1, Text Type: N, H10
[136610436]
As reported from the hospital - "stent slipped off the balloon (bib balloon catheter) while traversing through the femoral vascular sheath and had to be snared out with damaged struts through goose neck snare. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2019-00003 |
| MDR Report Key | 8282449 |
| Date Received | 2019-01-28 |
| Date of Report | 2019-01-28 |
| Date of Event | 2018-12-13 |
| Date Mfgr Received | 2019-01-03 |
| Device Manufacturer Date | 2017-08-02 |
| Date Added to Maude | 2019-01-28 |
| 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 | CP STENT |
| Generic Name | AORTIC STENT |
| Product Code | PNF |
| Date Received | 2019-01-28 |
| Returned To Mfg | 2019-01-10 |
| Model Number | 425 |
| Catalog Number | CP8Z39 |
| Lot Number | CP-0861 |
| 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 | 2019-01-28 |