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 26606
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/28/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that stent partially deployed was encountered.The target lesion was located in the common carotid artery.A 8.0-21 carotid wallstent monorail stent was advanced for treatment.However, during deployment, the stent did not fully deploy even if the outer sheath was pulled out.It was deployed beyond the limited marker and did a re-sheath.The device was retrieved and completed the procedure with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter city: (b)(6).Device evaluated by mfr: the stent was returned partially deployed from the delivery system.The distal stent wires were noted to be damaged.This type of damage is consistent with the stent encountering resistance during deployment.The investigator was unable to fully deploy the stent due solidified media within the delivery system.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the media before further deployment attempts were made.The device was removed from the bath and deployment of the stent was attempted but was still unsuccessful.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent partially deployed was encountered.The target lesion was located in the common carotid artery.A 8.0-21 carotid wallstent monorail stent was advanced for treatment.However, during deployment, the stent did not fully deploy even if the outer sheath was pulled out.It was deployed beyond the limited marker and did a re-sheath.The device was retrieved and completed the procedure with another of the same device.There were no patient complications reported.
 
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 Key10672883
MDR Text Key211314670
Report Number2134265-2020-14003
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 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/23/2024
Device Model Number26606
Device Catalogue Number26606
Device Lot Number0025763812
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2020
Initial Date Manufacturer Received 09/29/2020
Initial Date FDA Received10/13/2020
Supplement Dates Manufacturer Received11/03/2020
Supplement Dates FDA Received11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-