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 2020-01-30 for ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM SR-200-NPS manufactured by Silk Road Medical, Inc..
[179308905]
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). 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 lead to the adverse event reported. Complaints will continue to be monitored for any trends.
Patient Sequence No: 1, Text Type: N, H10
[179308906]
During a tcar procedure, the physician had difficulty engaging the external carotid due to the significant angle coming off of the common. After several unsuccessful attempts, the physician stopped. The guidewire was advanced to just short of the bifurcation, and the micropuncture sheath was exchanged with the nps arterial sheath. Two views were taken, but no dissection was visualized, and. 014" wire was advanced into right internal carotid artery. Wire quickly began to prolapse in right internal carotid artery and dissection was realized. Several attempts were made to pull arterial sheath tip back and work around dissection to no avail. Decision was made to convert to cea. Patient had successful cea, and came out of surgery with all vitals normal and neuro intact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014526664-2020-00009 |
| MDR Report Key | 9650274 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2017-05-04 |
| Date Mfgr Received | 2017-05-10 |
| 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 Phone | 4087209002 |
| 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 NEUROPROTECTION SYSTEM |
| Generic Name | TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE |
| Product Code | NTE |
| Date Received | 2020-01-30 |
| Model Number | SR-200-NPS |
| Catalog Number | SR-200-NPS |
| Lot Number | 200807 |
| Device Expiration Date | 2018-04-02 |
| 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. Required No Informationntervention | 2020-01-30 |