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

Model Number 26605

Device Problems Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906)

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

Event Date 08/24/2022

Event Type  Injury  

Event Description

It was reported that partial stent deployment occurred.The target lesion was located in the carotid artery.A 10.0-37 carotid wallstent was advanced to treat the lesion.However, when the stent was deployed halfway, the rear part of the stent would not deploy and the deployed part could not be re-constrained.The stent was later released by force using another device.The procedure was completed with no patient complications reported and the patient status was stable.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16797093
• MDR Text Key: 313842732
• Report Number: 2124215-2023-18512
• 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: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0028700740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 74 KG