MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-31 for COVERED CP STENT 427 CVRDCP8Z39 manufactured by Numed, Inc..
[119504114]
The detachment of the covering was confirmed. Four adhesive spots are visible on the covering. The od of the stent when shipped is 0. 181". The od of this stent is 0. 114", and there is significant twisting in the zig rows at each end of the stent. As stated in the report from the hospital, they were attempting to use this device in a 9 fr. Introducer. In the instructions for use provided with the device, it states that this device when mounted on a 12mm bib required a 12 fr. Introducer. It also states in the report that they crimped this device on the bib catheter with umbilical tape. This is not the recommended method that is stated in the instructions for use. Between crimping this device with umbilical tape and trying to pass it into an introducer 3 sizes smaller than the rated introducer size, most likely caused the covering to detach. A sample from each lot of stents is tested for covering adhesion strength. The sample from this lot failed at 3. 01lbs, which is well above the 1. 5lb minimum acceptance criteria.
Patient Sequence No: 1, Text Type: N, H10
[119504115]
As reported by bis "teflon cover detached from the stent. The indication the physician was using the product for: coarctation repair. The balloon the stent was mounted on: 12x4 bib. The crimping process used: crimped using umbilical tape and light finger pressure. The ring mandril was used during the crimping process. The stent did not slip. The covering became detached as the bib/stent was being advanced into the sheath using the loader provided with the stent. There was no difficulty encountered while inserting the bib/stent into the introducer. The blue introducer tool provided by numed was used. Account did not attempt to pull the stent back through the hemostasis valve. Saline media was used during prep. The balloon was not inflated. A 9f introducer sheath was used. There was nothing unusual about the patient anatomy. The catheter shaft was not kinked. The patient condition post procedure was normal". "the 12f hemostasis tool was used".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2018-00011 |
| MDR Report Key | 7838037 |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-31 |
| Date of Event | 2018-08-17 |
| Date Mfgr Received | 2018-08-21 |
| Device Manufacturer Date | 2017-07-26 |
| Date Added to Maude | 2018-08-31 |
| 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 | 2018-08-31 |
| Returned To Mfg | 2018-08-23 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z39 |
| Lot Number | CCP-0802 |
| 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 | 2018-08-31 |