MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-29 for COVERED CP STENT 427 CVRDCP8Z34 manufactured by Numed, Inc..
[85283034]
The stent was returned and evaluated. The stent had been crimped down so small that the zigs at the end of the stent are overlapped (see picture attachments). One glue spot was detached. There are weak spots in the covering that appear to have been caused when the covering was pinched between the struts during crimping. This stent is only approved to be used on 12mm - 24mm balloons. Anything smaller than that can damage the stent. It is likely that the crimping of the stent down on such a small balloon led to the weak spots in the covering. A warning in the instructions for use states :"crimping the stent on a balloon catheter smaller than 12mm may cause damage to the stent. "
Patient Sequence No: 1, Text Type: N, H10
[85283035]
As per the report from bis - "physician was crimping the stent on the balloon. After crimping, physician noticed what appeared to be some tears in the material that were not believed to be caused by the physician. The stent was removed and another stent placed. The stent was being mounted on a 10x3. 5 bib. There was no difficulty mounting the stent. Crimping was done by hand. The ring mandril was not used during crimping. The stent did not slip. The slight tears in the covering of the stent were not believed to be caused by the crimping process. Contrast was being used during prep. Physician was using the product for severe coarctation of aorta. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2017-00025 |
| MDR Report Key | 6826600 |
| Date Received | 2017-08-29 |
| Date of Report | 2017-08-29 |
| Date of Event | 2017-08-15 |
| Date Mfgr Received | 2017-08-18 |
| Device Manufacturer Date | 2016-02-24 |
| Date Added to Maude | 2017-08-29 |
| 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 | 2017-08-29 |
| Returned To Mfg | 2017-08-21 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z34 |
| Lot Number | CCP-0660 |
| Operator | PHYSICIAN |
| 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 | 2017-08-29 |