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

Model Number	M001719050
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the delivery system could not be removed resulting to blood loss.The 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.However, post successful stent deployment, the delivery system was stuck on the non-boston scientific (non-bsc) guidewire and could not be removed.The delivery system and non-bsc wire were pulled out as one unit, and the wire access was lost.Consequently, the patient experienced blood loss.There was no treatment provided to the patient, as the blood loss was not significant enough to require giving the patient blood.The patient fully recovered, and there were no complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the compliant device was returned to our post market quality assurance laboratory.The device was returned loaded on to the customers guidewire and was in a deployed state.The investigator was unable to remove the guidewire from the device while in a fully deployed state.The investigator was unable to retract the stainless-steel shaft and was unable to put the device 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 deployed stent was not returned for analysis.There were no issues noted with the stent cups or stent holders.This concludes the product analysis.
Event or Problem Description
It was reported that the delivery system could not be removed resulting to blood loss.The 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.However, post successful stent deployment, the delivery system was stuck on the non-boston scientific (non-bsc) guidewire and could not be removed.The delivery system and non-bsc wire were pulled out as one unit, and the wire access was lost.Consequently, the patient experienced blood loss.There was no treatment provided to the patient, as the blood loss was not significant enough to require giving the patient blood.The patient fully recovered, and there were no complications as a result of this event.
Event or Problem Description
It was reported that the delivery system could not be removed resulting to blood loss.The 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.However, post successful stent deployment, the delivery system was stuck on the non-boston scientific (non-bsc) guidewire and could not be removed.The delivery system and non-bsc wire were pulled out as one unit, and the wire access was lost.Consequently, the patient experienced blood loss.There was no treatment provided to the patient, as the blood loss was not significant enough to require giving the patient blood.The patient fully recovered, and there were no complications as a result of this event.
Additional Manufacturer Narrative
This report is being submitted to correct the correction/removal reporting # (h9) in section h, device manufacturers only.Device evaluated by mfr: the compliant device was returned to our post market quality assurance laboratory.The device was returned loaded on to the customers guidewire and was in a deployed state.The investigator was unable to remove the guidewire from the device while in a fully deployed state.The investigator was unable to retract the stainless-steel shaft and was unable to put the device 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 deployed stent was not returned for analysis.There were no issues noted with the stent cups or stent holders.This concludes the product analysis.

• 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: 22170630
• Report Number: 2124215-2025-36610
• Device Sequence Number: 9382722
• Product Code: NIM
• UDI-Device Identifier: 08714729781127
• UDI-Public: (01)08714729781127(17)280826(10)35939213
• 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
• Report Date (Section B): 08/19/2025

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
• Operator of Device: Health Professional
• Device Model Number: M001719050
• Device Catalogue Number: M001719050
• Device Lot Number: 0035939213
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 07/03/2025; 08/04/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/30/2025; 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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 - SPIDERFX; GUIDEWIRE - SPIDERFX; GUIDEWIRE - SPIDERFX
• Patient Sex: Unknown