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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SILK ROAD MEDICAL, INC. SILKROAD MEDICAL ENROUTE TRANSCAROTID STENT SYSTEM; STENT, CAROTID

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SILK ROAD MEDICAL, INC. SILKROAD MEDICAL ENROUTE TRANSCAROTID STENT SYSTEM; STENT, CAROTID Back to Search Results
Catalog Number SR-0930-CS
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2021
Event Type  Injury  
Event Description
A (b)(6) year old male undergoing tcar procedure.After carotid stent deployment, it was noticed on fluoro that the radiopaque tip of the stent delivery system had came apart from the system.Silkroad medical ref.# (b)(4),lot# 17933389, enroute transcarotid stent system 9mm x 30mm.Object was subsequently snared and removed from the body.After speaking with the company rep.We were told this is a known issue with certain lots of this device.We were not made aware of this pre-procedure.This device was not included in the previously affected lots known to the company rep.No apparent impact to the patient and otherwise successful procedure.Fda safety report id # (b)(4).
 
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Brand Name
SILKROAD MEDICAL ENROUTE TRANSCAROTID STENT SYSTEM
Type of Device
STENT, CAROTID
Manufacturer (Section D)
SILK ROAD MEDICAL, INC.
sunnydale CA
MDR Report Key11285874
MDR Text Key230744875
Report NumberMW5099248
Device Sequence Number1
Product Code NIM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Catalogue NumberSR-0930-CS
Device Lot Number17933389
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2021
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient Weight71
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