MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-27 for COVERED AND MOUNTED CP STENT 428 CMCP027 manufactured by Numed, Inc..
[78608480]
The device was implanted and not returned to numed. The hemostasis valve tools were not fully inserted in either case, which would cause the stent to catch on the hemostasis valve. This is most likely the cause of the stent migration/dislodgement. This complaint involved two cmcp-1558. Same physician, same hospital, two different patients on the same day. The second report is number 1318694-2017-00018. Device implanted and not returned.
Patient Sequence No: 1, Text Type: N, H10
[78608481]
As per the report from distributor - "after unsheathing the stent in the desired location and the inner balloon was inflated, it was determined that the stent had partially slid off the balloon. The doctor was able to partially inflate the outer balloon, deflate, move, and properly expand the remainder of the stent. The end result was perfect placement and the gradient was no longer present. Saline was used during prep. The 14f hemostasis tool provided by numed was used. Physician did not attempt to pull the stent back through the neostasis valve at any time. " clarification from bis specialist - sent on 6/22/2017 - "the physician did use the tools provided by numed, however, the physician did not insert the insertion sleeve far enough. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2017-00017 |
| MDR Report Key | 6669198 |
| Date Received | 2017-06-27 |
| Date of Report | 2017-06-27 |
| Date of Event | 2017-05-25 |
| Date Mfgr Received | 2017-05-31 |
| Device Manufacturer Date | 2017-03-08 |
| Date Added to Maude | 2017-06-27 |
| 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 AND MOUNTED CP STENT |
| Generic Name | AORTIC STENT |
| Product Code | PNF |
| Date Received | 2017-06-27 |
| Model Number | 428 |
| Catalog Number | CMCP027 |
| Lot Number | CMCP-1558 |
| 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 | 2017-06-27 |