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: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; 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
 

BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID Back to Search Results
Model Number 26605
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2021
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.The 91% stenosed target lesion was located in the neck vessel.A 10.0-31 carotid wallstent was advanced for treatment.However, it was noted that the tip of the stent was not aligned with the delivery shaft.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
 
Manufacturer Narrative
Device evaluated by mfr: a carotid wallstent device was received for analysis and was consistent with the reported event.The device was returned with the stent partially deployed.The first two stent struts rows were damaged.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.
 
Event Description
It was reported that stent damage occurred.The 91% stenosed target lesion was located in the neck vessel.A 10.0-31 carotid wallstent was advanced for treatment.However, it was noted that the tip of the stent was not aligned with the delivery shaft.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CAROTID WALLSTENT
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12629039
MDR Text Key276385598
Report Number2134265-2021-12434
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/05/2024
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0025671356
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2020
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 Age59 YR
Patient SexFemale
Patient Weight57 KG
-
-