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

Model Number 26605

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 11/08/2021

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 08dec2021.It was reported that partial deployment occurred.The target lesion was located in a carotid artery.A 10.0-24 carotid wallstent was selected for used.However, during unpacking, it was noticed that stent was partially deployed.The procedure was completed with another of same device.No patient complications were reported.However, device analysis revealed that stent fully deployed and detached from the delivery system.

Manufacturer Narrative

Device evaluated by mfr.: a carotid device was returned for analysis.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.The device was returned with the stent fully deployed and detached from the delivery system.No damage or issues were noted with the deployed stent.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: 13087263
• MDR Text Key: 282781937
• Report Number: 2134265-2021-16189
• 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
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• 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: 0027039484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2021
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 65 KG