MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-21 for COVERED AND MOUNTED CP STENT 428 CMCP026 manufactured by Numed, Inc..
[68279831]
The root cause of the complaint cannot be positively determined since the device was implanted in the patient and not returned. Films of the procedure were sent to numed to review but did not include videos of when the sheath was actually retracted and the stent fully exposed before inflation. The film skipped over that part of it and just showed the stent once the inner balloon had already been inflated. The stent was able to be used and the patient was fine post procedure.
Patient Sequence No: 1, Text Type: N, H10
[68279832]
As per the report from bis: "the stent went through the sheath fine. After unsheathing, it was noticed that the stent was mounted distally before inflation, it had migrated. The physician was about to use the stent, it was just difficult to use. The stent was being used for a small conduit tear. An inflation device with pressure gauge was used. The catheter shaft was not kinked. There was nothing unusual about the patient anatomy. The patient was fine post procedure. Saline and contrast were both used during prep. The physician did inflate the inner balloon before the outer balloon, and did not attempt to pull the stent back through the hemostasis valve at any time. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2017-00006 |
| MDR Report Key | 6347045 |
| Date Received | 2017-02-21 |
| Date of Report | 2017-02-21 |
| Date of Event | 2017-01-30 |
| Date Mfgr Received | 2017-01-31 |
| Device Manufacturer Date | 2016-09-20 |
| Date Added to Maude | 2017-02-21 |
| 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 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 | 2017-02-21 |
| Model Number | 428 |
| Catalog Number | CMCP026 |
| Lot Number | CMCP-1429 |
| 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 | 2017-02-21 |