MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2020-01-28 for ENROUTE TRANSCAROTID STENT SYSTEM SR-0840-CS manufactured by Silk Road Medical, Inc..
[179310405]
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. On 17dec2019 silk road medical contacted osb to inform them of medical device reports that were not reported within the mandatory reporting timeframe. It is noted here, per fda's request, that this mdr was identified as part of a complaint handling remediation effort associated with capa-(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[179310406]
It was reported that an asymptomatic patient underwent a transcarotid revascularization procedure on (b)(6) 2016. The patient experienced hemiparesis on the left side of the body within 24 hours. A ct/cta was performed which showed that the stent had recoiled and there was a thrombus in the right middle cerebral artery (mca). The patient also experienced multifocal atrial tachycardia (mat). A thrombectomy was performed on (b)(6) 2016 and the patient was released to a rehab facility on (b)(6) 2016. No additional details were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014526664-2020-00033 |
| MDR Report Key | 9640203 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date of Event | 2016-11-02 |
| Date Mfgr Received | 2016-11-02 |
| Date Added to Maude | 2020-01-28 |
| 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. |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer G1 | SILK ROAD MEDICAL, INC. |
| Manufacturer Street | 1213 INNSBRUCK DRIVE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94089 |
| 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 | 2020-01-28 |
| Model Number | SR-0840-CS |
| Catalog Number | SR-0840-CS |
| Lot Number | 200487 |
| Device Expiration Date | 2018-01-31 |
| 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 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-28 |