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U.S. Department of Health and Human Services

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

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SILK ROAD MEDICAL ENROUTE TRANSCAROTID STENT SYSTEM; ENROUTE SDS Back to Search Results
Model Number SR-1040-CS
Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seizures (2063)
Event Date 07/20/2020
Event Type  Injury  
Manufacturer Narrative
The product associated with this complaint was not returned to the manufacturer for analysis.An investigation into the reported event is underway and a follow up will be submitted once additional information is made available.
 
Event Description
A transcarotid artery revascularization (tcar) procedure was completed successfully in (b)(6) 2020.The patient returned in (b)(6) 2020 post-operative and showed seizure like symptoms upon hypotension noted by neurology and suggested hypoperfusion.A follow up ct scan was performed and showed narrowing in the enroute stent.A secondary (tcar) procedure was performed on (b)(6) 2020 where a hemashield dacron graft was placed at the proximal common carotid artery (cca).Noticeable stent fracture was seen on angio prior to (b)(6) 2020 angioplasty.Discussed adding a covered stent or additional enroute to cover fractures but physician opted angioplasty only.The patient woke up from surgery neurologically intact.As of the date of this report, there was no report of patient harm.
 
Manufacturer Narrative
The device investigation report was received and the following information was provided: a review of the manufacturing records and device history record (dhr) for this device was conducted and presented no issues during the manufacturing and inspection processes.A review of the lot did not yield any evidence that would support the conclusion that the stent involved in this complaint was nonconforming or that it contributed to the reported complaint.The review of the provided information such as photographs and lot history information concluded that there was no stent fracture and no issues were identified that could have led to the adverse event reported.
 
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Brand Name
ENROUTE TRANSCAROTID STENT SYSTEM
Type of Device
ENROUTE SDS
Manufacturer (Section D)
SILK ROAD MEDICAL
1213 innsbruck drive
sunnyvale, ca
MDR Report Key10418131
MDR Text Key203300629
Report Number3014526664-2020-00073
Device Sequence Number1
Product Code NIM
UDI-Device Identifier00811311020539
UDI-Public(01)00811311020539(17)210430(10)17865037
Combination Product (y/n)N
PMA/PMN Number
P140026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/11/2020
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 Date04/30/2021
Device Model NumberSR-1040-CS
Device Catalogue NumberSR-1040-CS
Device Lot Number17865037
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/20/2020
Initial Date FDA Received08/17/2020
Supplement Dates Manufacturer Received08/21/2020
Supplement Dates FDA Received09/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age77 YR
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