MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-26 for ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM SR-200-NPS manufactured by Silk Road Medical, Inc..
[189081818]
The product in complaint was not returned to the manufacturer for evaluation. A review of the manufacturing records for this device was completed and no issues were identified that could have lead to the adverse event reported. Complaints will continue to be monitored for any trends.
Patient Sequence No: 1, Text Type: N, H10
[189081819]
It was reported that a (b)(6) year old male patient underwent a right transcarotid artery revascularization (tcar) procedure on (b)(6) 2020. When the physician attempted to insert the enroute. 035 wire, it was not stabilized upon enroute sheath insertion. The physician pulled back from the external carotid into the proximal common carotid artery (cca) which appeared to cause a dissection in the patient's cca. The physician then attempted to rotate the sheath advance the wire, but this was unsuccessful. A decision was then made to close the arteriotomy with a pre-close stitch and re-access. The physician then placed new pre-close stitch slightly distal to prior access. The enhance. 018 access wire would not advance either, therefore the physician decided to close that access as well and convert to cea (carotid endarterectomy). The physician successfully performed the cea on the right internal carotid artery (rica). Using imaging to reassess post flow dynamics the physician noticed the dissection flap in the mid common carotid artery. The physician then gained retrograde access in the rica and proceeded with stenting (enroute stent 8x30) the mid rica in a retrograde fashion. The physician was satisfied with the final imaging and completed the case. The patient was extubated and was able to follow commands, moving all 4 extremities without difficulty. No additional details were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014526664-2020-00040 |
| MDR Report Key | 9758478 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-02-26 |
| 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 Street | 1213 INNSBRUCK DR. SUNNYVALE, |
| Manufacturer City | SUNNYVALE, CA |
| Manufacturer Country | US |
| Manufacturer G1 | SILK ROAD MEDICAL, INC. |
| Manufacturer Street | 1213 INNSBRUCK DR |
| Manufacturer City | SUNNYVALE,, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM |
| Generic Name | TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE |
| Product Code | NTE |
| Date Received | 2020-02-26 |
| Model Number | SR-200-NPS |
| Catalog Number | SR-200-NPS |
| Lot Number | 300818 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SILK ROAD MEDICAL, INC. |
| Manufacturer Address | 1213 INNSBRUCK DR. SUNNYVALE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-26 |