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

Model Number 26605

Device Problems Difficult or Delayed Positioning (1157); Mechanical Problem (1384)

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

Event Date 02/08/2023

Event Type  malfunction  

Event Description

It was reported that the stent not fully re-constrained during removal.The 85% stenosed target lesion was located in the non-calcified and non-tortuous carotid artery.Angiography found stenosis of the beginning segment of the left internal carotid aneurysm.After the filter wire was in place and the balloon was inflated, a 10.0-31 carotid wallstent monorail was advanced to treat the lesion.The sheath was then retracted, and the tip of the stent was normally deployed; however, during the stent deployment, the sheath could not be retracted further.So, the stent was retracted and replaced.However, it was not fully re-constrained prior to withdrawal.The procedure was completed with another of same device.No patient complications were reported, and the patient status was stable.

Event Description

It was reported that the stent not fully reconstrained during removal.The 85% stenosed target lesion was located in the non-calcified and non-tortuous carotid artery.Angiography found stenosis of the beginning segment of the left internal carotid aneurysm.After the filter wire was in place and the balloon was inflated, a 10.0-31 carotid wallstent monorail was advanced to treat the lesion.The sheath was then retracted, and the tip of the stent was normally deployed; however, during the stent deployment, the sheath could not be retracted further.So, the stent was retracted and replaced.However, it was not fully reconstrained prior to withdrawal.The procedure was completed with another of same device.No patient complications were reported, and the patient status was stable.

Manufacturer Narrative

Device evaluated by mfr: only the deployed stent of the device was returned for analysis.A visual examination found the distal stent wires to be damaged.The carotid delivery system was not returned for analysis.This concludes the product analysis.

• 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: 16522228
• MDR Text Key: 311069802
• Report Number: 2124215-2023-10150
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• 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: 0029818823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2022
• 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: 76 YR
• Patient Weight: 60 KG