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

Model Number 26605

Device Problems Break (1069); Positioning Failure (1158)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

E1: (b)(6).

Event Description

It was reported that shaft break occurred.The target lesion was located in the severely stenosed left carotid artery.A 10.0-37 carotid monorail stent was advanced for treatment.An 8f guide catheter and a bsc filter were placed, then pre-dilation was performed with a balloon.The stent was delivered to the lesion location.However, during deployment, the delivery system fractured and the stent could not be deployed.The device was removed and another of the same device was successfully implanted.The patient was stable and there were no complications reported.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).Device was returned to the manufacturer: the carotid monorail was returned with the stent partially deployed from the device.A visual examination found that the complete outer sheath was separated.The stent could not be deployed due to the sheath damage.No kinking was identified.No other damages or issues were noted.This concludes the product analysis.

Event Description

It was reported that shaft break occurred.The target lesion was located in the severely stenosed left carotid artery.A 10.0-37 carotid monorail stent was advanced for treatment.An 8f guide catheter and a bsc filter were placed, then pre-dilation was performed with a balloon.The stent was delivered to the lesion location.However, during deployment, the delivery system fractured and the stent could not be deployed.The device was removed and another of the same device was successfully implanted.The patient was stable and there were no complications 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: 18369330
• MDR Text Key: 331030462
• Report Number: 2124215-2023-71982
• 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: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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: 0031080589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2023
• 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: 58 YR
• Patient Weight: 80 KG