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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SILK ROAD MEDICAL INC. ENROUTE TRANSCAROTID STENT SYSTEM; ENROUTE SDS

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SILK ROAD MEDICAL INC. ENROUTE TRANSCAROTID STENT SYSTEM; ENROUTE SDS Back to Search Results
Model Number SR-1040-CS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 10/30/2020
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 silk road medical 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 after the completion of a transcarotid artery revascularization (tcar) procedure, the patient experienced stroke-like symptoms.He underwent a secondary tcar procedure where fresh thrombus was discovered inside the 10x40 stent that had been deployed.Once the physician had access and was setup on flow reversal he was able to cross the stent and initially ballooned the lesion inside the stent with a 3x20 balloon to irritate the lesion and have flow reversal push it into our filter in the flow controller.There appear to be more lesion distal to the initial lesion and exchanged the.014 enroute wire to a.014 thruway wire with the assistance of a quick-cross catheter.The physician went over the wire and was able to see fresh thrombus distal to the stent.The physician proceeded to cover that lesion with a 10x40 stent that extended into the proximal portion of the original stent.After a final completion angiogram, the physician determined that the configuration of the stents looked good and there was no thrombus lingering inside the stent or distal to the stent.The patient has made a full recovery and is neurologically intact.
 
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Brand Name
ENROUTE TRANSCAROTID STENT SYSTEM
Type of Device
ENROUTE SDS
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
4087309002
MDR Report Key10871496
MDR Text Key217436517
Report Number3014526664-2020-00115
Device Sequence Number1
Product Code NIM
UDI-Device Identifier00811311020539
UDI-Public(01)00811311020539(17)211231(10)17924458
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 11/19/2020
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 Expiration Date12/31/2021
Device Model NumberSR-1040-CS
Device Catalogue NumberSR-1040-CS
Device Lot Number17924458
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/30/2020
Initial Date FDA Received11/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/31/2019
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) Required Intervention; Disability;
Patient Age66 YR
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