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 2020-01-30 for ENROUTE NEUROPROTECTION SYSTEM SR-200-NPS manufactured by Silk Road Medical, Inc..

Event Text Entries

[179312612] 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


[179312613] It was reported that a patient underwent a transcarotid revascularization procedure on (b)(6) 2017. It was noted that a dissection occurred upon delivery of the arterial sheath. The sheath was removed and the dissection plane was repaired with a patch. However, a dissection was still noted, therefore a dracon graft was implanted. The tcar procedure was then performed successfully. No additional details were provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3014526664-2020-00013
MDR Report Key9649998
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-30
Date of Report2020-01-30
Date of Event2017-11-27
Date Mfgr Received2017-11-27
Date Added to Maude2020-01-30
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 DR.
Manufacturer CitySUNNYVALE CA 94089
Manufacturer CountryUS
Manufacturer Postal94089
Manufacturer G1SILK ROAD MEDICAL, INC.
Manufacturer Street1213 INNSBRUCK DRIVE
Manufacturer CitySUNNYVALE CA 94089
Manufacturer CountryUS
Manufacturer Postal Code94089
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 Received2020-01-30
Model NumberSR-200-NPS
Catalog NumberSR-200-NPS
Lot Number200960
Device Expiration Date2018-08-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSILK ROAD MEDICAL, INC.
Manufacturer Address1213 INNSBRUCK DR. SUNNYVALE CA 94089 US 94089


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-30

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