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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-0930-CS
Device Problems Break (1069); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2020
Event Type  malfunction  
Manufacturer Narrative
The product associated with this complaint was returned to the manufacturer for analysis.The distal tip was not returned for analysis.Nevertheless, per microscopic analysis, scanning electron microscopy (sem) tests results showed that the separated area of the inner shaft of the unit presented evidence of elongations and cup and cone shape-like.Braid wires on the inner shaft presented evidence of plastic deformation, diameter reduction and ductile dimples on their surface.The previously mentioned damages are commonly associated with separations caused by material tensile overload.The cause of the material separation observed on the inner shaft, the bent condition of the body/shaft of the catheter, and the partial deployment of the stent could not be conclusively determined during the analysis.The reported failure is not related to the manufacturing process of the unit.A review of manufacturing records for this device was completed and no issues were identified that could have led to the adverse event reported 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 during a trans-carotid artery revascularization (tcar) procedure, the stent would not pass through the lesion.While pulling the stent back, the distal tip of the stent delivery system came off, and remained in the carotid artery.The physician made the decision to convert the procedure to a carotid endarterectomy (cea), and successfully removed the marker, and the carotid was fixed.There was no report of patient harm.
 
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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 Key10674067
MDR Text Key213496901
Report Number3014526664-2020-00091
Device Sequence Number1
Product Code NIM
UDI-Device Identifier00811311020492
UDI-Public(01)00811311020492(17)211130(10)17917092
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 10/13/2020
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? Yes
Device Operator Health Professional
Device Expiration Date11/30/2021
Device Model NumberSR-0930-CS
Device Catalogue NumberSR-0930-CS
Device Lot Number17917092
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/14/2020
Initial Date FDA Received10/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2019
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 Age87 YR
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