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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
Device Problem Material Deformation (2976)
Patient Problem Insufficient Information (4580)
Event Date 04/21/2023
Event Type  Injury  
Event Description
It was reported that stent damage occurred requiring additional intervention.On (b)(6) 2023, the patient presented for carotid stenting.A carotid monorail (carotid wallstent) was implanted for treatment.On (b)(6) 2023, the same patient returned to the healthcare facility.A new carotid monorail wallstent was implanted by a different physician.Following implantation of the new stent, the physician informed the patient that the stent implanted on (b)(6) 2023 had collapsed.The procedure was completed with no further patient complications reported.
 
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Brand Name
CAROTID WALLSTENT
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key17002584
MDR Text Key315930440
Report Number2124215-2023-22727
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/25/2023
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/27/2023
Initial Date FDA Received05/25/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Outcome(s) Required Intervention;
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