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

Model Number 26605

Device Problems Break (1069); Positioning Failure (1158); Difficult to Advance (2920)

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

Event Date 02/17/2023

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The patient presented with right common carotid artery entrapment and underwent stenting.A 10.0-37 carotid wallstent was advanced for treatment.However, during introduction, resistance was encountered.After reaching the target lesion, it was found that the outer sheath was fractured and the stent could not be deployed.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by mfr.: carotid wallstent monorail 10.0-37 was received for analysis.The device was received with the stent fully constrained in the correct position on the delivery system.The investigator successfully deployed the stent without issue.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 shaft separation or damage along the length of the device.

Event Description

It was reported that shaft break occurred.The patient presented with right common carotid artery entrapment and underwent stenting.A 10.0-37 carotid wallstent was advanced for treatment.However, during introduction, resistance was encountered.After reaching the target lesion, it was found that the outer sheath was fractured and the stent could not be deployed.The procedure was completed with another of same device.There were 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: 16517727
• MDR Text Key: 311084448
• Report Number: 2124215-2023-08648
• 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,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0028895186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/09/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2022
• 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 Age: 48 YR
• Patient Weight: 62 KG