ENROUTE NEUROPROTECTION SYSTEM SR-200-NPS

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number3014526664-2020-00042
MDR Report Key9751064
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-25
Date of Report2020-02-25
Date of Event2020-02-11
Date Mfgr Received2020-02-11
Date Added to Maude2020-02-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street1213 INNSBRUCK DRIVE
Manufacturer CitySUNNYVALE, CA
Manufacturer CountryUS
Manufacturer G1SILK ROAD MEDICAL, INC
Manufacturer Street1213 INNSBRUCK DRIVE
Manufacturer CitySUNNYVALE, CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENROUTE NEUROPROTECTION SYSTEM
Generic NameTEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
Product CodeNTE
Date Received2020-02-25
Model NumberSR-200-NPS
Catalog NumberSR-200-NPS
Lot Number300818
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSILK ROAD MEDICAL, INC
Manufacturer Address1213 INNSBRUCK DRIVE SUNNYVALE, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-25

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