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

Model Number 26605

Device Problems Detachment of Device or Device Component (2907); Positioning Problem (3009)

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

Event Date 03/02/2023

Event Type  Injury  

Event Description

It was reported that position difficulty occurred, requiring an additional stent to be placed.A carotid wallstent was selected for use in a carotid procedure.The lesion was noted to be 65% stenosed.During deployment of the stent, the hub detached from the metal shaft.As a result, the stent could not be positioned correctly.The upper end of the stent was just inside the stenosis and required two dilatations.An additional stent was required to cover the remainder of the lesion.The stent was post-dilated one time.No further patient complications were reported.

Manufacturer Narrative

H6.Impact code updated.

Event Description

It was reported that position difficulty occurred, requiring an additional stent to be placed.A carotid wallstent was selected for use in a carotid procedure.The lesion was noted to be 65% stenosed.During deployment of the stent, the hub detached from the metal shaft.As a result, the stent could not be positioned correctly.The upper end of the stent was just inside the stenosis and required two dilatations.An additional stent was required to cover the remainder of the lesion.The stent was post-dilated one time.No further patient complications were reported.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16657088
• MDR Text Key: 312445772
• Report Number: 2124215-2023-13953
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• 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: 0030868066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• 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 Outcome(s): Required Intervention
• Patient Sex: Male