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

Model Number 26605

Device Problems Failure to Advance (2524); Material Integrity Problem (2978)

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

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1: (b)(6).Device evaluated by mfr.: carotid wallstent monorail 8.0-29 was received for analysis.The device was received with the stent fully constrained in the correct position on the delivery system.The stent and shaft were found to be kinked at the same location at the center of the stent.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination the shaft delivery system and stent to be kinked at the same location at the center of the undeployed stent.This type of damage is consistent with excessive force being applied to the device.A visual examination found no damage or issues with the tip of the device.

Event Description

Reportable based on device analysis completed on 28-feb-2023.It was reported that tip damage and crossing difficulties were encountered.The 90% stenosed target lesion was located in the severely tortuous and mildly calcified internal carotid artery.A 8.0-29 carotid wallstent monorail stent was advanced but failed to cross the lesion and it was noticed that the tip was out of shape.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed a stent damage.

• 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: 16585103
• MDR Text Key: 311757059
• Report Number: 2124215-2023-09829
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• 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: 0030286096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2022
• 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