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

Model Number 26605

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2020

Event Type  malfunction  

Event Description

It was reported that reported that the stent partially deployed.The target lesion was located in the highly tortuous right internal carotid artery (ica).An 8.0-36 carotid wallstent was selected for the procedure.During the procedure, the stent was advanced and stent deployment was initiated.However, stent deployment stopped after the 80% of the stent opened.There was a click observed in the catheter and it was impossible to fully open the stent.The entire delivery system and stent were able to be pulled back and removed.The procedure was completed with another device.There were no patient complications and the patient status was stable post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the returned device consisted of carotid monorail.The device was received with the stent in the correct position on the delivery system.The stent could not be deployed due to a complete break in the outer shaft of the device and solidified media inside the delivery system.A visual and tactile inspection of the catheter identified a complete break of the outer shaft located approximately 30mm distal of the main valve.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination identified no issues with the tip of the device.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

Event Description

It was reported that reported that the stent partially deployed.The target lesion was located in the highly tortuous right internal carotid artery (ica).An 8.0-36 carotid wallstent was selected for the procedure.During the procedure, the stent was advanced and stent deployment was initiated.However, stent deployment stopped after the 80% of the stent opened.There was a click observed in the catheter and it was impossible to fully open the stent.The entire delivery system and stent were able to be pulled back and removed.The procedure was completed with another device.There were no patient complications and the patient status was stable post procedure.It was further reported that the 60% stenosed target lesion was located in the and highly calcified and very tortuous right ica.It was a tough stenosis and not easy to pass.The stent was fully reconstrained without issue after the deployment failure.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10650859
• MDR Text Key: 210463585
• Report Number: 2134265-2020-13871
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

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 Expiration Date: 05/29/2023
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0024847133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR