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

Model Number 26605

Device Problems Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)

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

Event Date 12/12/2022

Event Type  malfunction  

Event Description

It was reported that stent was unable to be reconstrained.The target lesion was located in the carotid artery.An 8.0-36 carotid wallstent was advanced to treat the lesion.However, during the procedure, the stent was difficult to deploy.It was noticed that the knob would not move as the thumb wheel was stuck.The stent was partially deployed, less than 50%.The device was directly removed, and the procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

A carotid device was received for analysis.A visual and tactile examination identified no issues with the catheter or delivery system or the handle of the device.The device was returned with the stent fully mounted in the correct location on the device.The investigator deployed the stent without any issue.No damage or issues were noted with the deployed stent.This concludes the product analysis.

Event Description

It was reported that stent was unable to be reconstrained.The target lesion was located in the carotid artery.An 8.0-36 carotid wallstent was advanced to treat the lesion.However, during the procedure, the stent was difficult to deploy.It was noticed that the knob would not move as the thumb wheel was stuck.The stent was partially deployed, less than 50%.The device was directly removed, and the procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16247533
• MDR Text Key: 308194350
• Report Number: 2124215-2023-02736
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0029963349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2022
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 58 KG