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

Model Number 26605

Device Problems Difficult or Delayed Positioning (1157); Material Deformation (2976)

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

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter address, city, phone: (b)(6).Carotid wallstent monorail 8.0-21 was received for analysis.A visual and tactile examination identified a complete separation of the outer sheath of the device located approximately 30mm distal of the main t-valve.This type of damage is consistent with excessive force being applied to the device when attempting deployment.No kinking of the delivery system was identified.The device was returned with the stent in the correct position on the delivery system.The investigator was unable to deploy the stent due to a separation of the outer sheath of the device.

Event Description

Reportable based on device analysis completed on 02aug2023.It was reported that shaft kink occurred.The 90% stenosed target lesion was located in the internal carotid artery.An 8.0-21 carotid monorail was selected for use.However, the delivery shaft was noted to be kinked, and during the procedure, the stent could not be deployed.The procedure was completed with another of same device.There were no patient complications reported.However, returned device analysis found the outer sheath of the device to be separated.

• 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: 17608085
• MDR Text Key: 321821750
• Report Number: 2124215-2023-41088
• 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: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• 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: 0029397229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2022
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 63 KG