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 TRANSCAROTID STENT SYSTEM SR-0740-CS manufactured by Silk Road Medical, Inc.
[187262724]
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 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
[187262725]
It was reported that an (b)(6) year old female underwent a right transcarotid revascularization procedure on (b)(6) 2020. Patient has a history of prior cea. Pre op scan was performed which appeared to have none to mild calcium in the lesion. There was however, visible disease within the cea patched area from the internal carotid artery ica to the distal common carotid artery (cca). All tcar instruments were put in place without incidence. Physician pre dilated balloon. The physician deployed a 0740 stent without complication, under proper flow reversal. Implant appeared to have no residual stenosis post angiogram. However, post op ct scan showed that the stent was compressed to the point where the physician explanted the day after implant. Patient is stable post explant. No additional details have been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014526664-2020-00038 |
| MDR Report Key | 9751315 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-29 |
| 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 TRANSCAROTID STENT SYSTEM |
| Generic Name | ENROUTE SDS |
| Product Code | NIM |
| Date Received | 2020-02-25 |
| Model Number | SR-0740-CS |
| Catalog Number | SR-0740-CS |
| Lot Number | 300238 |
| 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 |