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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE TRANSCAROTID STENT SYSTEM; ENROUTE TSS

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SILK ROAD MEDICAL ENROUTE TRANSCAROTID STENT SYSTEM; ENROUTE TSS Back to Search Results
Model Number SR-1040-CS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Event Date 01/08/2024
Event Type  Injury  
Manufacturer Narrative
A secondary mdr was reported under 3014526664-2024-00028 as there are two stents associated with the same event/patient.The product associated with this 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 led to the adverse event reported.There is no indication that a malfunction of the srm device occurred.At this time, it is unknown if the reported event is related to procedural issues, medication non-compliance or a silk road medical device failure, hence, the event will be reported out of abundance of caution.Complaints will continue to be reviewed and monitored for trends.All reasonably available information has been provided by the company at the time of submission of this report.The fields that are blank are not an omission and indicate that the information is either not applicable or currently unavailable.If additional information is received, a supplemental report will be filed.
 
Event Description
It was reported that after a right transcarotid artery revascularization (tcar) procedure, the patient suffered a stroke with left side stroke symptoms.Imaging revealed thrombus within the stent and thrombectomy was performed.At this time, it is unknown if the reported event is related to procedural issues, medication non-compliance or a silk road medical device failure, hence, the event will be reported out of abundance of caution.
 
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Brand Name
ENROUTE TRANSCAROTID STENT SYSTEM
Type of Device
ENROUTE TSS
Manufacturer (Section D)
SILK ROAD MEDICAL
1213 innsbruck drive
sunnyvale CA 94089
Manufacturer (Section G)
SILK ROAD MEDICAL
1213 innsbruck drive
sunnyvale CA 94089
Manufacturer Contact
shelrin devi
1213 innsbruck drive
sunnyvale, CA 94089
4087209002
MDR Report Key18625737
MDR Text Key334346461
Report Number3014526664-2024-00015
Device Sequence Number1
Product Code NIM
UDI-Device Identifier00811311020539
UDI-Public(01)00811311020539(17)250331(10)18104098
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/01/2024
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-1040-CS
Device Catalogue NumberSR-1040-CS
Device Lot Number18104098
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/08/2024
Initial Date FDA Received02/01/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/21/2022
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) Disability; Required Intervention;
Patient Age79 YR
Patient SexMale
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