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

Model Number 26606

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

It was reported that removal difficulties were encountered.The approximately 85% stenosed target lesion was located in the mildly tortuous left internal carotid arteries.A 3.5mm x 40mm x 135cm (4f) sterling balloon catheter was advanced for pre-dilatation; however, slight friction was felt on the proximal side of the non-boston scientific guidewire while guiding the balloon catheter.A 6.0-22 carotid wallstent monorail was advanced for use.However, a slight friction was encountered while inserting the device into the patient's body.The device was removed, and subsequently, a 10.0-31 carotid wallstent monorail was also advanced.But a slight friction was also encountered while inserting the device into the patient's body.The process was continued, and both stents were successfully deployed.The system was then attempted to be removed from the body, but severe friction was felt that prevented the system from being easily pulled out.The procedure was completed with the original device.No patient complications were reported, and patient was in good condition post-procedure.

Manufacturer Narrative

H6-component codes: corrected and updated from stent to catheter.Device evaluated by mfr: carotid wallstent monorail 6.0-22 was received for analysis.The following attributes were considered during analysis.This carotid device is recommended for use with a 0.014-inch (0.36mm) guidewire as per carotid wallstent instructions for use.During the product analysis a boston scientific 0.014-inch filterwire could not be advanced through the device due to the presence of solidified media within the wire lumen.The device was placed in a water bath at 27degrees in an attempt to soften the media.The investigator attempted to load the device on to the guidewire a second time but was unsuccessful.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.The deployed stent was not returned for analysis.

Event Description

It was reported that removal difficulties were encountered.The approximately 85% stenosed target lesion was located in the mildly tortuous left internal carotid arteries.A 3.5mmx40mmx135cm (4f) sterling balloon catheter was advanced for pre-dilatation; however, slight friction was felt on the proximal side of the non-boston scientific guidewire while guiding the balloon catheter.A 6.0-22 carotid wallstent monorail was advanced for use.However, a slight friction was encountered while inserting the device into the patient's body.The device was removed, and subsequently, a 10.0-31 carotid wallstent monorail was also advanced.But a slight friction was also encountered while inserting the device into the patient's body.The process was continued, and both stents were successfully deployed.The system was then attempted to be removed from the body, but severe friction was felt that prevented the system from being easily pulled out.The procedure was completed with the original device.No patient complications were reported, and patient was in good condition post-procedure.

• 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: 17906641
• MDR Text Key: 326250039
• Report Number: 2124215-2023-54142
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 11/03/2023

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: 26606
• Device Catalogue Number: 26606
• Device Lot Number: 0029702132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Male