MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2020-01-30 for ENROUTE TRANSCAROTID STENT SYSTEM UNKNOWN manufactured by Silk Road Medical, Inc.
[179312778]
The product in complaint was not identified by a lot number nor returned to the manufacturer for analysis. 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
[179312779]
It was reported in a publication titled "endovascular today" that a patient underwent a transcarotid revascularization (tcar) procedure. Event date is unknown) the patient was slow to arouse, unable to follow major commands, and not moving the left upper or left lower extremity. Immediate cta showed acute occlusion of the ica stent without intracranial bleed. On axial imaging, the stent was noted to be compressed into an ovoid shape. The patient emergently returned to the operating room and the previous incision was reentered. Arteriography demonstrated thrombus burden. Due to the potential stent fracture, the previous stent was relined with a 6- x 40-mm zilver ptx drug-eluting stent (cook medical) and postdilated with a 5- x 40-mm angioplasty balloon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014526664-2020-00025 |
| MDR Report Key | 9650545 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Device Manufacturer Date | 2018-12-10 |
| Date Added to Maude | 2020-01-30 |
| 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 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 | 2020-01-30 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| 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 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2020-01-30 |