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

Model Number 26665

Device Problems Positioning Failure (1158); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2021

Event Type  malfunction  

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 282394062
• Report Number: 2134265-2021-15901
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08714729781103
• UDI-Public: 08714729781103
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male