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 Problems Difficult or Delayed Positioning (1157); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2021
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled.The target lesion was located in the carotid artery.A 10.0-31 carotid wallstent was advanced for treatment.However, it was observed that the stent could not be deployed smoothly resulting in an accurate positioning.The physician was able to reconstrain the stent and the device was simply pulled out from the patient's body.The procedure was cancelled.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The device was returned to the complaint investigation site with the stent fully crimped onto the delivery system.The stent was fully constrained.The stent was successfully deployed without issue.No issues were noted with the stent.A visual and microscopic investigation identified no issues with the stent cup, stent holder or tip that could have contributed to the complaint incident.A visual and tactile examination of the device identified no issues or any damage with the catheter.No issues were identified during the product analysis.
 
Event Description
It was reported that the procedure was cancelled.The target lesion was located in the carotid artery.A 10.0-31 carotid wallstent was advanced for treatment.However, it was observed that the stent could not be deployed smoothly resulting in an accurate positioning.The physician was able to reconstrain the stent and the device was simply pulled out from the patient's body.The procedure was cancelled.No patient complications were reported and the patient's 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
MDR Report Key11484163
MDR Text Key240021404
Report Number2134265-2021-03304
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/25/2022
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0023857405
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2021
Date Manufacturer Received03/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age56 YR
Patient Weight80
-
-