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..
[78817925]
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 1318694-2017-00017.
Patient Sequence No: 1, Text Type: N, H10
[78817926]
As per the report from distributor - "as physician was preparing to inflate the inner balloon. It was determined that the stent had partially slid off the balloon. Physician realized the entire system had to be removed, the stent came completely off the balloon and was left in the descending aorta. Physician quickly moved back in with the sheath and was able to get the tip of the sheath to partially insert into the end of the stent, as the end flared a bit. Physician then came in with a snare and grabbed the sheath from the proximal end, and then moved the stent forward to the approximate target area. Next, physician inserted a 22mm balloon and successfully expanded the cp stent with perfect placement. After this step was completed it was realized that on both this case and the previous case, physician did not insert the blue insertion sleeve through the valve of the sheath. The 14f hemostasis tool provided by numed was used. Physician did not attempt to pull the stent back through the hemostasis 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. The physician did not try to pull stent back out until after it began to come off the balloon. The physician then tried to pull it back once the stent was partially off the balloon, but before the physician got to that point, the stent came completely off the balloon. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2017-00018 |
| MDR Report Key | 6669202 |
| 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 |