MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-22 for COVERED CP STENT 427 CVRDCP8Z22 manufactured by Numed, Inc..
[75873623]
Stent returned to numed completely mangled - see attached pictures. The covering was not returned. Further analysis is not possible due to the condition of the stent and the absence of the covering. The detachment of the covering is confirmed. This was the physician's first time using this device unaided, so it is likely that inexperience played a role in the failure. The report states that the physician used " 16 and 18" f hemostasis tools to insert the stent in to a 12f introducer. Numed only provides 12, 14 and 16f hemostasis tools with unmounted stents. If a 16f hemostasis tool was used with a 12f introducer, the distal end of the hemostasis tool would have collapsed, making it difficult to advance the stent. The use of umbilical tape to crimp the stent may have also contributed to the failure. Numed recommends crimping the stent by hand. Crimping instructions are included in the instructions for use and there is an instructional video on numed's website. A sample from this lot was tested for covering strength. The covering failed at 1. 74 lbf, which is above the 1. 5 lbf minimum. This complaint was for (2) covered cp stents. The other stent will be reported through mdr # 1318694-2017-00013.
Patient Sequence No: 1, Text Type: N, H10
[75873664]
As reported by braun: " crimped on to bib balloon, inserted to sheath with the hemostasis tool the cover came back and rolled off. This happened two times. Went in and out of the hemostasis valve multiple times physician re-crimped it. Account said it could be operator error, physician's first time using stent unaided. As stent was advancing through, it kept coming off of the balloon. There was no difficulty mounting the balloon. The size of the catheter the stent was mounted on: 16 mm x 4. 5 cm both, 2. 2 stent 3. 4 stent. Both saline and contrast media were used during prep. The hemostasis tools were used that are provided by numed - the sizes: 16 and 18. The stent started slipping during insertion through the sheath. The inner balloon was inflated before the outer balloon once the 2 successful stents were deployed. They attempted to pull the stent back through the hemostasis valve to get it out. Crimping process used: ring mandril through end of balloon with stent on it, put it in between markers (2 outer image bands) compressed with thumb and index rolled it. Used umbilical tape to wrap around stent and further crimp down. The indication the physician was using the balloon for - co-arc. An inflation device with pressure gauge was used. The size and type of introducer sheath used - 12 f long mullin. The catheter shaft was not kinked. There was nothing unusual about the patient anatomy. The patient condition post procedure: patient ok. Successfully placed 3. 9 and 3. 4 stents. Used 3. 9 w/ 12f 16 x 4. 5 3. 4 14f sheath and 16 x 3. 5. " on 5/11/2017 - from a conversation the bis sale specialist had with the account: "sequence of events - crimped on to bib balloon. Inserted into sheath with the hemostasis tool. Was unable to advance into sheath, physician attempted to advance multiple times and the cover would come back and roll off. Physician stated this happened when attempted two times. After removing again, physician attempted to re-crimp it, and was unsuccessful as the cover rolled off again. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2017-00012 |
| MDR Report Key | 6581063 |
| Date Received | 2017-05-22 |
| Date of Report | 2017-05-19 |
| Date of Event | 2017-04-17 |
| Date Mfgr Received | 2017-04-28 |
| Date Added to Maude | 2017-05-22 |
| 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. MELISSA THOMAS |
| Manufacturer Street | 2880 MAIN STREET |
| Manufacturer City | HOPKINTON NY 12965 |
| Manufacturer Country | US |
| Manufacturer Postal | 12965 |
| 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 | 2017-05-22 |
| Returned To Mfg | 2017-05-17 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z22 |
| Lot Number | CCP-0671 |
| 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 | 2017-05-22 |