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

Model Number 26606

Device Problem Failure to Advance (2524)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 12/02/2020

Event Type  Injury  

Event Description

It was reported that vessel perforation occurred.The 99% stenosed target lesion was located in the severely tortuous and non-calcified internal carotid artery.A bsc filterwire was placed in position and the lesion was pre-dilated with a sterling balloon.A 8.0-29 carotid wallstent was the advanced to the lesion.The device had difficulties in crossing but eventually crossed and the stent was placed without further problems.Subsequently, the lumen was viewed with an opticross 18 imaging catheter and post-dilatation using a 6mm sterling balloon.Bleeding was observed from the center of the stent.Protamine was injected, dilatation using a 6mm balloon was performed, and the neck region was compressed to stop the bleeding and the procedure was completed.The patient left the operating room without symptoms.Physician commented that the bleeding might have been caused by the stent getting caught while passing through the stenosis.No further patient complications were reported.

Event Description

It was reported that vessel perforation occurred.The 99% stenosed target lesion was located in the severely tortuous and non-calcified internal carotid artery.A bsc filterwire was placed in position and the lesion was pre-dilated with a sterling balloon.A 8.0-29 carotid wallstent was the advanced to the lesion.The device had difficulties in crossing but eventually crossed and the stent was placed without further problems.Subsequently, the lumen was viewed with an opticross 18 imaging catheter and post-dilatation using a 6mm sterling balloon.Bleeding was observed from the center of the stent.Protamine was injected, dilatation using a 6mm balloon was performed, and the neck region was compressed to stop the bleeding and the procedure was completed.The patient left the operating room without symptoms.Physician commented that the bleeding might have been caused by the stent getting caught while passing through the stenosis.No further patient complications were reported.It was further reported that vessel perforation was not reported.

• 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: 11004477
• MDR Text Key: 221484419
• Report Number: 2134265-2020-17551
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: 26606
• Device Catalogue Number: 26606
• Device Lot Number: 0024839009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER USED: STERLING 3.5/X30; BALLOON CATHETER USED: STERLING 3.5/X30; GUIDEWIRE USED: FILTERWIRE; GUIDEWIRE USED: FILTERWIRE; BALLOON CATHETER USED: STERLING 3.5/X30; GUIDEWIRE USED: FILTERWIRE
• Patient Outcome(s): Required Intervention