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

Model Number	M001719060
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The patient presented with a stroke which required the deployment of two carotid wallstents.The greater than 75% stenosed target lesion was located in the mildly tortuous and mildly calcified carotid artery.The first carotid wallstent was successfully deployed in the target location.Post stent deployment, it was noted that the stent delivery system became stuck with non-boston scientific wire.Both wire and delivery system were removed together which resulted in a loss of wire access.Wire access was re-established with a new non-bsc guidewire.The second carotid wallstent was advanced and deployed without issue.However, post-deployment, the delivery system also became stuck with the non-boston scientific wire.Both the wire and delivery system were removed together.The procedure was completed at this point.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that device entrapment occurred.The patient presented with a stroke which required the deployment of two carotid wallstents.The greater than 75% stenosed target lesion was located in the mildly tortuous and mildly calcified carotid artery.The first carotid wallstent was successfully deployed in the target location.Post stent deployment, it was noted that the stent delivery system became stuck with non-boston scientific wire.Both wire and delivery system were removed together which resulted in a loss of wire access.Wire access was re-established with a new non-bsc guidewire.The second carotid wallstent was advanced and deployed without issue.However, post-deployment, the delivery system also became stuck with the non-boston scientific wire.Both the wire and delivery system were removed together.The procedure was completed at this point.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.This device is recommended for use with a 0.014 inch (0.36mm) guidewire as per the instructions for use (ifu).The device was returned loaded on to the customer's guidewire and was noted to be in a deployed state.The investigator was unable to remove the guidewire from the device.The device was soaked in a water bath at a temperature of 37 degrees celsius for several days to help soften any solidified media present within the guidewire lumen.The device was then removed from the water bath and after considerable manipulation the investigator was still unable to remove the guidewire.The stainless-steel shaft was retracted to re-sheath the delivery system and the investigator was able to remove the guidewire without any issue.The device was flushed without any issue with the guidewire removed.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.No other issues were identified during the product analysis.
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 device was returned for evaluation.This device is recommended for use with a 0.014 inch (0.36mm) guidewire as per the instructions for use (ifu).The device was returned loaded on to the customer's guidewire and was noted to be in a deployed state.The investigator was unable to remove the guidewire from the device.The device was soaked in a water bath at a temperature of 37 degrees celsius for several days to help soften any solidified media present within the guidewire lumen.The device was then removed from the water bath and after considerable manipulation the investigator was still unable to remove the guidewire.The stainless-steel shaft was retracted to re-sheath the delivery system and the investigator was able to remove the guidewire without any issue.The device was flushed without any issue with the guidewire removed.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.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that device entrapment occurred.The patient presented with a stroke which required the deployment of two carotid wallstents.The greater than 75% stenosed target lesion was located in the mildly tortuous and mildly calcified carotid artery.The first carotid wallstent was successfully deployed in the target location.Post stent deployment, it was noted that the stent delivery system became stuck with non-boston scientific wire.Both wire and delivery system were removed together which resulted in a loss of wire access.Wire access was re-established with a new non-bsc guidewire.The second carotid wallstent was advanced and deployed without issue.However, post-deployment, the delivery system also became stuck with the non-boston scientific wire.Both the wire and delivery system were removed together.The procedure was completed at this point.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned loaded on to the customer's guidewire and was noted to be in a deployed state.This device is recommended for use with a 0.014-inch (0.36mm) guidewire as per the instructions for use (ifu).The investigator was unable to remove the guidewire from the device.The device was soaked in a water bath at a temperature of 37 degrees celsius for several days to help soften any solidified media present within the guidewire lumen.The device was then removed from the water bath and after considerable manipulation the investigator was still unable to remove the guidewire.The stainless-steel shaft was retracted to re-sheath the delivery system and the investigator was able to remove the guidewire without any issue.The device was flushed without any issue with the guidewire removed.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.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that device entrapment occurred.The patient presented with a stroke which required the deployment of two carotid wallstents.The greater than 75% stenosed target lesion was located in the mildly tortuous and mildly calcified carotid artery.The first carotid wallstent was successfully deployed in the target location.Post stent deployment, it was noted that the stent delivery system became stuck with non-boston scientific wire.Both wire and delivery system were removed together which resulted in a loss of wire access.Wire access was re-established with a new non-bsc guidewire.The second carotid wallstent was advanced and deployed without issue.However, post-deployment, the delivery system also became stuck with the non-boston scientific wire.Both the wire and delivery system were removed together.The procedure was completed at this point.There were no patient complications as a result of this event.

• 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: 22090040
• Report Number: 2124215-2025-31351
• Device Sequence Number: 6947621
• Product Code: NIM
• UDI-Device Identifier: 08714729781141
• UDI-Public: (01)08714729781141(17)280530(10)35388279
• 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): 08/22/2025

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: M001719060
• Device Catalogue Number: M001719060
• Device Lot Number: 0035388279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 07/07/2025; 08/04/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 07/18/2025; 08/04/2025; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2024
• 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: SCIENTIA ZOOM 14 X-SUPPORT; GUIDEWIRE: SCIENTIA ZOOM 14 X-SUPPORT; GUIDEWIRE: SCIENTIA ZOOM 14 X-SUPPORT; GUIDEWIRE: SCIENTIA ZOOM 14 X-SUPPORT
• Patient Age: 75 YR
• Patient Sex: Male