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

Model Number 26605

Device Problems Difficult to Advance (2920); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/17/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 20dec2023.It was reported that the sheath was kinked and difficulty to deliver occurred.The severe stenosed target lesion was located in the c1 segment of the carotid artery.A 10.0-24 carotid monorail stent was selected for treatment, but upon unpacking, it was found that its delivery shaft was kinked and had difficulty to deliver.The stent was replaced by another of the same device.There were no patient complications reported.However, returned device analysis revealed that the sheath was kinked and separated.The steel shaft was also kinked.

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).E1: initial reporter address 2: (b)(6).The carotid monorail was returned for analysis and it was noted that the stent was in the correct position on the delivery system.A visual examination found the sheath to be kinked and separated.The steel shaft was also found to be kinked.As the damage was identified when being unpacked, the kink to the shaft most likely occurred due excessive force being applied when it was in storage at the facility.The shaft kink would have contributed to the difficulty advancing the device.The sheath kink and separation discovered during the analysis most probably occurred due to an unintentional interaction between the user and the device.The kinking and separation of the inner sheath could not be established from the information provided.

• 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: 18521822
• MDR Text Key: 332978507
• Report Number: 2124215-2023-75999
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• 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: 0031640845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2023
• 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: 70 KG