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

Model Number 26665

Device Problem Entrapment of Device (1212)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

It was reported that an entrapment on the guidewire occurred.The 40-50% stenosed target lesion was located in the mildly tortuous and moderately calcified left internal carotid artery.An 8x29, 5f, 135cm carotid monorail was advanced to assist in deploying a carotid wallstent.Deployment was successful, but the wallstent catheter was stuck on the distal protection device wire of a non-bsc device and could not removed, thus, was entrapped.The physician attempted to free the catheter by pinning it and advancing the wire, but was unsuccessful.The entire system was taken out together with both devices as one unit.The catheter remained stuck after it was retrieved.The procedure was completed successfully.

Manufacturer Narrative

The stent was returned to the manufacturer for analysis deployed from the delivery system.A visual and tactile examination identified no issues with the catheter or delivery system.The non-bsc guidewire that was used together with the carotid monorail was kinked.It was confirmed this stent met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.

Event Description

It was reported that an entrapment on the guidewire occurred.The 40-50% stenosed target lesion was located in the mildly tortuous and moderately calcified left internal carotid artery.An 8x29, 5f, 135cm carotid monorail was advanced to assist in deploying a carotid wallstent.Deployment was successful, but the wallstent catheter was stuck on the distal protection device wire of a non-bsc device and could not removed, thus, was entrapped.The physician attempted to free the catheter by pinning it and advancing the wire, but was unsuccessful.The entire system was taken out together with both devices as one unit.The catheter remained stuck after it was retrieved.The procedure was completed successfully.It was further confirmed that there was resistance encountered during the removal of the stent delivery system over the wire.

• 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: 18360737
• MDR Text Key: 330956269
• Report Number: 2124215-2023-72053
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08714729781202
• UDI-Public: 08714729781202
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26665
• Device Catalogue Number: 26665
• Device Lot Number: 0032188276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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: 70 YR
• Patient Sex: Male