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

Model Number 26605

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

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

Event Date 08/25/2023

Event Type  malfunction  

Event Description

It was reported that catheter entrapment occurred.The 50% stenosed target lesion was located in the mildly tortuous and non-calcified internal carotid artery.A 10.0-24 carotid wallstent was advanced for treatment.However, during the procedure the stent stuck on a non-boston scientific (bsc) wire and could not advance further.Hence, the device was removed by forcefully pulling out.Another stent was used, and the procedure was completed.There were no patient complications reported.

Event Description

It was reported that catheter entrapment occurred.The 50% stenosed target lesion was located in the mildly tortuous and non-calcified internal carotid artery.A 10.0-24 carotid wallstent was advanced for treatment.However, during the procedure the stent stuck on a non-boston scientific (bsc) wire and could not advance further.Hence, the device was removed by forcefully pulling out.Another stent was used, and the procedure was completed.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: the carotid wallstent monorail 10.0-24 was returned for analysis.This carotid device is recommended for use with a 0.014" (0.36mm) guidewire as per instructions for use.During the product analysis a boston scientific 0.014" filterwire was successfully inserted through this device with no resistance experienced or lumen obstruction encountered.The guidewire used by the customer was not returned for analysis.A visual and tactile examination identified no damage or issues with the delivery system.The device was returned with the stent fully deployed from the device.No issues were noted with the deployed stent.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17793972
• MDR Text Key: 323981493
• Report Number: 2124215-2023-49041
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• 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: 0030655687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2022
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 60 KG