MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-29 for COVERED CP STENT 427 CVRDCP8Z34 manufactured by Numed, Inc..
[146495089]
The introducer, catheter, stent covering and hemostasis tools were all returned for evaluation. The covering was completely detached from the stent but intact. The stent was implanted in the patient with no issues or complications. The hemostasis tools were undamaged. The bib catheter was passed through the d'vill introducer. A slight catch was felt at the transition between the flange and the sheath. The hemostasis valve was removed from the introducer. One side of the flange had not been heated enough, leaving part of the sheath tubing exposed. A 0. 110" gauge pin was passed through the transition. The pin caught on the exposed tubing. The complaint was confirmed since the covering had detached from the stent. It appears that the covering caught on the exposed end of the sheath tubing at the bond between the flange and the tubing. It is likely that the covering would have remained attached if not for this issue. All covered cp stents are inspected in final qc to ensure each covering has (4) acceptable glue spots. A sample from each lot is test for covering strength. The sample from this lot had a covering strength of 2. 41lbs, which is well above the 1. 5lb acceptance criteria.
Patient Sequence No: 1, Text Type: N, H10
[146495090]
As per the incident report form received from the distributor - "patient with severe aortic coractation. Angioplasty with a covered cp stent was performed. During removal of the bib balloon the ptfe covering of the stent was found at the haemostatic membrane of the long sheath. After examination of the ptfe there was no piece missing. Patient remoained stable with no gradient across the arch. " no intervention required. "finally there was no adverse event and the coarctation was treated with a "non-covered" cp stent. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2019-00013 |
| MDR Report Key | 8651387 |
| Date Received | 2019-05-29 |
| Date of Report | 2019-05-29 |
| Date of Event | 2019-03-14 |
| Date Mfgr Received | 2019-05-03 |
| Device Manufacturer Date | 2018-07-11 |
| Date Added to Maude | 2019-05-29 |
| 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 | 2019-05-29 |
| Returned To Mfg | 2019-05-10 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z34 |
| Lot Number | CCP-0908 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-05-29 |