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

Model Number	M001719050
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient experienced blood loss or hemorrhage.The over 75% stenosed target lesion was located in the mildly tortuous and mildly calcified carotid artery.A 10x31,5.9f,135cm carotid wallstent was selected for treatment.During the procedure, it was noted that the physician experienced difficulty advancing the device over the non-boston scientific wire.After the stent was deployed, extreme difficulty in removing the delivery system was noted.The delivery system was successfully removed, but the patient had a blood loss as a result of this event.The stent remains implanted, and the patient fully recovered after the procedure.
Event or Problem Description
It was reported the device was difficult to remove.The over 75% stenosed target lesion was located in the mildly tortuous and mildly calcified carotid artery.A 10x31,5.9f,135cm carotid wallstent was selected for treatment.During the procedure, it was noted that the physician experienced difficulty advancing the device over the non-boston scientific wire.After the stent was deployed, extreme difficulty in removing the delivery system was noted.The delivery system was successfully removed, but the patient had a blood loss as a result of this event.The stent remains implanted, and the patient fully recovered after the procedure.It was further reported that there was no treatment provided after the patient had a blood loss, and the patient is doing well post-procedure.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.
Event or Problem Description
It was reported the patient experienced blood loss or hemorrhage.The over 75% stenosed target lesion was located in the mildly tortuous and mildly calcified carotid artery.A 10x31,5.9f,135cm carotid wallstent was selected for treatment.During the procedure, it was noted that the physician experienced difficulty advancing the device over the non-boston scientific wire.After the stent was deployed, extreme difficulty in removing the delivery system was noted.The delivery system was successfully removed, but the patient had a blood loss as a result of this event.The stent remains implanted, and the patient fully recovered after the procedure.It was further reported that there was no treatment provided after the patient had a blood loss, and the patient is doing well post-procedure.It was further reported that the blood loss was due to loss of wire access.There was no vessel trauma or access site complication.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.This device is recommended for use with a 0.014" (0.36mm) guidewire as per the instructions for use (ifu).The device was returned with no guidewire inserted in the device, and the device was in a deployed state.The investigator was unable to advance a boston scientific guidewire onto the device in a deployed state.The investigator retracted the stainless-steel shaft and was able to advance the guidewire onto the device and remove it without any issues in a undeployed state.A visual and tactile examination identified no issues with the catheter or delivery system.The device was returned with the stent fully deployed from the delivery system.The stent was not returned for analysis.There were no issues noted with the stent cups or stent holders.The inability to advance or remove a guidewire from the device when it was in the fully deployed state was confirmed.
Event or Problem Description
It was reported the device was difficult to remove and patient experienced blood loss.The over 75% stenosed target lesion was located in the mildly tortuous and mildly calcified carotid artery.A 10x31,5.9f,135cm carotid wallstent was selected for treatment.During the procedure, it was noted that the physician experienced difficulty advancing the device over the non-boston scientific wire.After the stent was deployed, extreme difficulty in removing the delivery system was noted.The delivery system was successfully removed, but the patient had a blood loss as a result of this event.The stent remains implanted, and the patient fully recovered after the procedure.It was further reported that there was no treatment provided for the blood loss, and the patient is doing well post-procedure.It was further reported that the blood loss was due to loss of wire access.There was no vessel trauma or access site complication.

• Brand Name: CAROTID WALLSTENT
• Common Device Name: 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: 21829796
• Report Number: 2124215-2025-22459
• Device Sequence Number: 9253486
• Product Code: NIM
• UDI-Device Identifier: 08714729781127
• UDI-Public: (01)08714729781127(17)280523(10)35347265
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P050019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001719050
• Device Catalogue Number: M001719050
• Device Lot Number: 0035347265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 04/16/2025; 06/01/2025; 07/10/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 05/15/2025; 06/24/2025; 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 97434080-FA
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - MEDTRONIC SPIDERFX .014 WIRE; GUIDEWIRE - MEDTRONIC SPIDERFX .014 WIRE; GUIDEWIRE - MEDTRONIC SPIDERFX .014 WIRE; GUIDEWIRE - MEDTRONIC SPIDERFX .014 WIRE
• Patient Age: 63 YR
• Patient Sex: Female