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

Model Number 26605

Device Problem Premature Activation (1484)

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

Event Date 12/03/2023

Event Type  malfunction  

Event Description

It was reported that inadvertent deployment occurred.The target lesion was located in the proximal internal carotid artery.A carotid wallstent was selected for use.However, during delivery, stent dislodged from the delivery system while still outside the patient.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the carotid wallstent was received for analysis.The device was received with the stent fully deployed from 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.

Event Description

It was reported that inadvertent deployment occurred.The target lesion was located in the proximal internal carotid artery.A carotid wallstent was selected for use.However, during delivery, stent dislodged from the delivery system while still outside the patient.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 18371473
• MDR Text Key: 331365333
• Report Number: 2124215-2023-71983
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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: 0031998219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2023
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 60 KG