Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Silk Road Medical ENROUTE Transcarotid Stent; Stent, Carotid
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

Silk Road Medical ENROUTE Transcarotid Stent; Stent, Carotid Back to Search Results
Model Number FG11815
Medical Device Problem Code Premature Activation (1484)
Health Effect - Clinical Code Extravasation (1842)
Date of Event 08/05/2026
Type of Reportable Event Serious Injury
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENROUTE Transcarotid Stent
Common Device Name
Stent, Carotid
Manufacturer (Section D)
Silk Road Medical
1213 innsbruck drive
sunnyvale CA 94089
Manufacturer (Section G)
CORDIS US CORP
14201 nw 60th avenue
miami lakes FL 33014
Manufacturer Contact
mark mischke
4100 hamline ave n
arden hills, MN 55112
+1(612)875-7234
MDR Report Key50571956
Report Number2124215-2026-46926
Device Sequence Number10196297
Product Code NIM
UDI-Device Identifier00811311021277
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2026
Device Explanted Year2026
Reporter Type Manufacturer
Report Source Health Professional,Company Representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/02/2026
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
Operator of Device Health Professional
Device Model NumberFG11815
Device Catalogue NumberFG11815
Device Lot Number0018520244
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/05/2026
Initial Report FDA Received Date09/02/2026
Date Device Manufactured10/25/2025
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age52 YR
Patient SexFemale
-
-