MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID

Model Number	26665
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the stent was bent.A carotid wallstent was selected for use in a coronary artery stenting procedure.During the procedure, after the stent passed the lesion, the stent was not able to deploy.The stent tip was found to be bent and was then removed.The procedure was successfully completed with a different device.There were no patient complications and the patient is fine.
Event or Problem Description
It was reported the stent was bent.A carotid wallstent was selected for use in a coronary artery stenting procedure.During the procedure, after the stent passed the lesion, the stent was not able deploy.The stent tip was found to be bent and was removed.The procedure was successfully completed with a different device.There were no patient complications and the patient is fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: a carotid device was returned for analysis.A visual and tactile examination identified that the tip of the device was bent.The device was returned with the stent fully mounted in the correct location on the device.The investigator deployed the stent without any issue.Damage was noted on the distal end of the stent.

• Brand Name: CAROTID WALLSTENT
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13019237
• Report Number: 2134265-2021-15901
• Device Sequence Number: 12006114
• Product Code: NIM
• UDI-Device Identifier: 08714729781103
• UDI-Public: 08714729781103
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P050019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2024
• Device Model Number: 26665
• Device Catalogue Number: 26665
• Device Lot Number: 0027324727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male