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U.S. Department of Health and Human Services

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

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SILK ROAD MEDICAL, INC. ENROUTE TANSCAROTID STENT SYSTEM; ENROUTE SDS Back to Search Results
Model Number SR-1040-CS
Device Problem Accessory Incompatible (1004)
Patient Problem Great Vessel Perforation (2152)
Event Date 06/01/2020
Event Type  Injury  
Manufacturer Narrative
In discussions with the silk road executive medical director, the extravasation being reported was due to a series of events.First, the lesion that was to be treated was highly calcified and not suitable for stenting.Second, the post-dilatation was very aggressive, forcing the stent against the calcified lesion.The end result was extravasation of the vessel.There have been only 8 extravasations reported in more than 16,000 transcarotid artery revascularization procedures.Complaint data will continue to be monitored for trends of extravasation.
 
Event Description
Patient underwent a left transcarotid artery revascularization.Patient had pre-dilatation with 6x30mm rapid exchange balloon followed by a successful delivery of a 10x40mm enroute stent.Following angiogram showed mild stenosis and post-dilatation was performed with 7x20mm rx balloon.Following angiogram showed extravasation of contrast at the distal portion of the stent.A 8x39mm gore viabahn vbx balloon expandable stent was placed at the distal portion of the enroute stent with approximately 1 cm overlap.Following angiogram showed improvement of extravasation.Patient woke up post-operatively at baseline mental status, following all verbal commands as well as moving all extremities appropriately to verbal commands.Follow up with surgeon the following morning, he reported the patient to be doing well with mild confusion which he attributed to her advanced age.
 
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Brand Name
ENROUTE TANSCAROTID STENT SYSTEM
Type of Device
ENROUTE SDS
Manufacturer (Section D)
SILK ROAD MEDICAL, INC.
1213 innsbruck drive
sunnyvale, ca
Manufacturer (Section G)
SILK ROAD MEDICAL, INC.
1213 innsbruck drive
sunnyvale, ca
Manufacturer Contact
sharon rideout
1213 innsbruck drive
sunnyvale, ca 
7209002
MDR Report Key10204438
MDR Text Key199898547
Report Number3014526664-2020-00060
Device Sequence Number1
Product Code NIM
UDI-Device Identifier00811311020539
UDI-Public(01)00811311020539(17)210930(10)17902998
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 06/27/2020
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 Date09/30/2021
Device Model NumberSR-1040-CS
Device Catalogue NumberSR-1040-CS
Device Lot Number17902998
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/01/2020
Initial Date FDA Received06/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2019
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;
Patient Age89 YR
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