ENROUTE TRANSCAROTID STENT SYSTEM SR-0640-CS

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 2020-02-18 for ENROUTE TRANSCAROTID STENT SYSTEM SR-0640-CS manufactured by Silk Road Medical, Inc.

Event Text Entries

[188712918] 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.
Patient Sequence No: 1, Text Type: N, H10


[188712919] It was reported that a (b)(6) male patient underwent a right transcarotid revascularization procedure on (b)(6) 2020. An extravasation occurred at the midportion of the 6x40 enroute stent. Therefore, a 6x2. 5 viabhan stent was placed inside of the enroute stent which successfully stopped the leak. The physician took final images and everything appeared fine. No additional details were provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3014526664-2020-00034
MDR Report Key9724089
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-18
Date of Report2020-02-18
Date of Event2020-01-21
Date Mfgr Received2020-01-21
Date Added to Maude2020-02-18
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 TRANSCAROTID STENT SYSTEM
Generic NameENROUTE SDS
Product CodeNIM
Date Received2020-02-18
Model NumberSR-0640-CS
Catalog NumberSR-0640-CS
Lot Number17880287
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 2020-02-18

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