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

Model Number 26605

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Transient Ischemic Attack (2109); Thromboembolism (2654)

Event Date 05/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the patient experienced a transient ischemic attack post procedure.The 90% stenosed target lesion was 30mm long with a 5-7mm diameter within the left internal carotid artery.A 5mm diameter non-bsc protection filter was placed.Subsequently, pre-dilation was performed using a 3.0mmx20mmx135cm sterling balloon.Stenting was performed with a 10.0-31 carotid wallstent.Post-dilation was completed using a 5.0mmx20mmx135cm sterling balloon.The devices all performed as intended without issue and the stent was fully apposed to the vessel wall.It was noted that the filter was very full of thrombotic particles.There were no complications during the procedure and the patient was well.One hour post procedure the patient experienced a transient ischemic attack (tia).The physician assessed the cause of the tia to be from thrombotic particles which floated past the filter.The physician thought the carotid wallstent caused the thrombotic particles.However, it was confirmed that no damage was noted on the carotid wallstent.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8713164
• MDR Text Key: 148452854
• Report Number: 2134265-2019-06811
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2021
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0021526977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2017
• 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 Outcome(s): Other