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 2020-02-25 for ENROUTE NEUROPROTECTION SYSTEM SR-200-NPS manufactured by Silk Road Medical, Inc.
[189081633]
The product in complaint was not returned to the manufacturer for analysis. A review of the manufacturing records for this device was completed and no issues were "identifed" 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
[189081634]
It was reported that a (b)(6) year old male underwent a right transcarotid revascularization procedure on (b)(6) 2020. There were no complications with access. However, after several attempts to cross the critical lesion, it was discovered that the wire was in a sub-intimal dissection plane. The dissection plane began at the level of the most proximal portion of the stenosis and continued shortly beyond the lesion distally. At this point, the tcar was aborted and the physician decided to convert to a carotid endarterectomy (cea). The patient had a successful cea and was discharged the following day without any events. No additional details were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014526664-2020-00042 |
| MDR Report Key | 9751064 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-02-25 |
| 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 DRIVE |
| Manufacturer City | SUNNYVALE, CA |
| Manufacturer Country | US |
| Manufacturer G1 | SILK ROAD MEDICAL, INC |
| Manufacturer Street | 1213 INNSBRUCK DRIVE |
| Manufacturer City | SUNNYVALE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENROUTE NEUROPROTECTION SYSTEM |
| Generic Name | TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE |
| Product Code | NTE |
| Date Received | 2020-02-25 |
| 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 DRIVE SUNNYVALE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-25 |