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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 Failure to Advance (2524); Material Deformation (2976); Positioning Problem (3009); Activation Failure (3270)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2020
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.Vascular access was obtained via femoral artery.The 60% stenosed, 7.0mm x 20mm, eccentric, de novo target lesion was located in the severely tortuous and mildly calcified carotid artery.After crossing the lesion with 8f guide catheter and 0.014 guidewire, a 10.0-31 carotid monorail stent was successfully advanced despite difficulty crossing the lesion.The stent was deployed.However, the stent did not fully expand after deployment.It was not well positioned and apposed after deployment.Compression to the distal part of the stent was also noted.The first stent was retrieved and another device, same model, was successfully used.No patient complications were reported and the patient status was stable.
 
Event Description
It was reported that stent damage occurred.Vascular access was obtained via femoral artery.The 60% stenosed, 7.0mm x 20mm, eccentric, de novo target lesion was located in the severely tortuous and mildly calcified carotid artery.After crossing the lesion with 8f guide catheter and 0.014 guidewire, a 10.0-31 carotid monorail stent was successfully advanced despite difficulty crossing the lesion.The stent was deployed.However, the stent did not fully expand after deployment.It was not well positioned and apposed after deployment.Compression to the distal part of the stent was also noted.The first stent was retrieved and another device, same model, was successfully used.No patient complications were reported, and the patient status was stable.
 
Manufacturer Narrative
Device eval by manufacturer: the device was not returned for analysis.An image provided by the customer confirmed that the stent had been partially deployed.No damage was noted to the distal section of the stent.
 
Manufacturer Narrative
H6.Device codes were updated.Device evaluation by manufacturer: a carotid wallstent monorail 10.0-31, batch # 25573932 was received back for analysis.A visual and tactile examination identified that the shrink tubing had detached at the distal edge of the main t-valve.The device was received with the stent partially deployed from the delivery system.There was no evidence of damage to this partially deployed stent.The investigator was unable to deploy the stent fully due to the damaged tubing.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent damage occurred.Vascular access was obtained via femoral artery.The 60% stenosed, 7.0mm x 20mm, eccentric, de novo target lesion was located in the severely tortuous and mildly calcified carotid artery.After crossing the lesion with 8f guide catheter and 0.014 guidewire, a 10.0-31 carotid monorail stent was successfully advanced despite difficulty crossing the lesion.The stent was deployed.However, the stent did not fully expand after deployment.It was not well positioned and apposed after deployment.Compression to the distal part of the stent was also noted.The first stent was retrieved and another device, same model, was successfully used.No patient complications were reported, and the patient status was stable.
 
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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 Key10637384
MDR Text Key210082586
Report Number2134265-2020-13392
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,Followup
Report Date 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/08/2023
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0025573932
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2021
Date Manufacturer Received03/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age79 YR
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