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

Model Number 26605

Device Problems Activation, Positioning or Separation Problem (2906); Migration (4003)

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

Event Date 11/17/2021

Event Type  malfunction  

Event Description

It was reported that stent migration occurred.The target lesion was located in the severely tortuous carotid artery.A 8.0-36 carotid wallstent was advanced for treatment.The stent reached the lesion; however, during deployment, it fell off downwards and was displaced.The stent was withdrawn and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

Event Description

It was reported that stent migration occurred.The target lesion was located in the severely tortuous carotid artery.A 8.0-36 carotid wallstent was advanced for treatment.The stent reached the lesion; however, during deployment, it fell off downwards and was displaced.The stent was withdrawn and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.As it was previously reported the device was "misplaced" but was able to be withdrawn, migration has been corrected to partial deployment.

Manufacturer Narrative

H6.Device codes: changed from migration to activation, positioning or separation problem.Device evaluated by manufacturer: the complaint device was received for analysis.The device was received with the stent in the correct position on the delivery system.The investigator successfully deployed the stent with a little resistance experienced due to the presence of solidified media within the delivery system.No damage was noted to the deployed stent.A visual inspection of the stent impression and stent cups identified no issues.The imprinted stent impression was clear on the stent holder.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified no issues along the length of the device.This concludes the product analysis.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12990755
• MDR Text Key: 282199241
• Report Number: 2134265-2021-15101
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

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: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0026920974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2021
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 62 KG