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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID
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BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID Back to Search Results
Model Number 26605
Device Problems Difficult or Delayed Positioning (1157); Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2021
Event Type  Injury  
Event Description
It was reported that reconstraining difficulties were encountered.The stenosed target lesion was located in the c1 section of the right carotid artery.A 10.0-37 carotid wallstent was advanced to treat the lesion.However, the stent was only deployed for 20-25% and could not be deployed completely.The stent could not be withdrawn to the sheath despite multiple attempts.An 8f bsc catheter was used to withdraw the stent from the patient in a not fully reconstrained state.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
 
Event Description
It was reported that reconstraining difficulties were encountered.The stenosed target lesion was located in the c1 section of the right carotid artery.A 10.0-37 carotid wallstent was advanced to treat the lesion.However, the stent was only deployed for 20-25% and could not be deployed completely.The stent could not be withdrawn to the sheath despite multiple attempts.An 8f bsc catheter was used to withdraw the stent from the patient in a not fully reconstrained state.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: a carotid device was returned for analysis.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.The device was returned with the stent deployed from the delivery system.No damage or issues were noted with the deployed stent.No issues were identified during the product analysis.
 
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Brand Name
CAROTID WALLSTENT
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12000108
MDR Text Key256225386
Report Number2134265-2021-07481
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 07/13/2021
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? Yes
Device Operator Health Professional
Device Expiration Date07/29/2023
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0025118260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2021
Initial Date Manufacturer Received 05/26/2021
Initial Date FDA Received06/15/2021
Supplement Dates Manufacturer Received06/25/2021
Supplement Dates FDA Received07/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age62 YR
Patient Weight70
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