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

Model Number 26605

Device Problem Difficult to Advance (2920)

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

Event Date 04/11/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 08-jul-2022.It was reported that tracking difficulties were encountered.The patient had right internal carotid artery occlusion and left carotid severe stenosis.The target lesion was located in the left carotid artery.After the filter wire was in placed, a 10.0-24 carotid wallstent was advanced for treatment.However, the tip of the device could not cross through the wire for many times.The physician removed and replaced the device with another of same device.The new stent could cross smoothly to reach the lesion position and was deployed well.The procedure was completed and there were no patient complications reported.The patient status was stable.However, returned device analysis revealed stent damage.

Manufacturer Narrative

Initial reporter facility name: (b)(6) hospital.Device evaluated by mfr.: a carotid device was returned for analysis.This carotid device is recommended for use with a 0.014 (0.36mm) guidewire.During the product analysis a boston scientific 0.014 filterwire was successfully inserted through this device with no resistance experienced.The guidewire used by the customer was not returned for analysis.A visual and tactile examination identified no kinks along the shaft.The device was returned with the stent fully mounted in the correct location on the device.The outer sheath was retracted by approximately 3mm exposing the distal stent struts.As a results the distal struts were misaligned.

• 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: 15161600
• MDR Text Key: 304042734
• Report Number: 2134265-2022-07952
• 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
• Report Date: 08/03/2022

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
• Device Operator: Health Professional
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0028092897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2021
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 55 KG