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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SILK ROAD MEDICAL INC. ENROUTE NEUROPROTECTION SYSTEM; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

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SILK ROAD MEDICAL INC. ENROUTE NEUROPROTECTION SYSTEM; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE Back to Search Results
Model Number SR-200-NPS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Numbness (2415); Ischemia Stroke (4418)
Event Date 08/17/2022
Event Type  Injury  
Manufacturer Narrative
The product associated with this complaint was not returned to the manufacturer for analysis.A review of manufacturing records for this device was completed and no issues were identified that could have led to the adverse event reported.Although there is no indication that a malfunction of the srm device occurred, the cause of the post-operative complication is unknown.A follow-up mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.
 
Event Description
It was reported that approximately 8 hours after the completion of a transcarotid artery revascularization (tcar) procedure, the patient experienced a small infarct (ischemic stroke).The patients symptoms included hand numbness and resolved within 48 hours with no reported intervention.
 
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Brand Name
ENROUTE NEUROPROTECTION SYSTEM
Type of Device
TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
Manufacturer (Section D)
SILK ROAD MEDICAL INC.
1213 innsbruck drive
sunnyvale CA 94089
Manufacturer (Section G)
SILK ROAD MEDICAL INC.
1213 innsbruck drive
sunnyvale CA 94089
Manufacturer Contact
magaly boardman
1213 innsbruck drive
sunnyvale, CA 94089
4087209002
MDR Report Key15459735
MDR Text Key300295286
Report Number3014526664-2022-00146
Device Sequence Number1
Product Code NTE
UDI-Device Identifier00811311020829
UDI-Public(01)00811311020829(17)240922(10)302187
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153485
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberSR-200-NPS
Device Catalogue NumberSR-200-NPS
Device Lot Number302187
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/24/2022
Initial Date FDA Received09/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age80 YR
Patient SexMale
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