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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 TSS

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SILK ROAD MEDICAL INC. ENROUTE TRANSCAROTID STENT SYSTEM; ENROUTE TSS Back to Search Results
Model Number SR-1030-CS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 09/21/2021
Event Type  Injury  
Manufacturer Narrative
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.Complaints will continue to be reviewed and monitored for trends.
 
Event Description
It was reported that during a transcarotid artery revascularization (tcar) procedure, a dissection was identified on the left internal carotid artery during stent placement angiogram which led the physician to intervene by covering the dissection with a secondary stent to resolve.Per silk road medical's field representative, it was noted that the physician wasn't sure if the dissection was caused by the balloon or stent, and it is believed that the physician leaned toward the stent.However, he did not perform imaging after the balloon angioplasty so there is no way to be certain.The procedure was completed successfully and the patient's clinical condition after the procedure completion remained neurologically intact.
 
Event Description
It was reported that during a transcarotid artery revascularization (tcar) procedure, a dissection was identified on the left internal carotid artery during stent placement angiogram which led the physician to intervene by covering the dissection with a secondary stent to resolve.Per silk road medical's field representative, it was noted that the physician wasn't sure if the dissection was caused by the balloon or stent, and it is believed that the physician leaned toward the stent.However, he did not perform imaging after the balloon angioplasty so there is no way to be certain.The procedure was completed successfully and the patient's clinical condition after the procedure completion remained neurologically intact.
 
Manufacturer Narrative
A follow-up mdr is being submitted to reflect the correct model number and catalog number under section d4: additional device information.
 
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Brand Name
ENROUTE TRANSCAROTID STENT SYSTEM
Type of Device
ENROUTE TSS
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 Key12551133
MDR Text Key274054877
Report Number3014526664-2021-00149
Device Sequence Number1
Product Code NIM
UDI-Device Identifier00811311020522
UDI-Public(01)00811311020522(17)240229(10)18011799
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,Followup
Report Date 11/05/2021
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 Date02/29/2024
Device Model NumberSR-1030-CS
Device Catalogue NumberSR-1030-CS
Device Lot Number18011799
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/28/2020
Initial Date FDA Received09/29/2021
Supplement Dates Manufacturer Received09/28/2020
Supplement Dates FDA Received11/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2021
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) Required Intervention;
Patient Age87 YR
Patient SexFemale
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