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

Model Number 26605

Device Problems Malposition of Device (2616); Difficult to Advance (2920)

Patient Problem Vasoconstriction (2126)

Event Date 11/13/2018

Event Type  Injury  

Event Description

It was reported that a vasospasm and stent placement issues occurred.A 10.0-24mm carotid monorail stent was selected for use during a whole brain angiography for the patient's carotid stenosis.However, during insertion and before the stent delivery system (sds) reached the lesion, the tip of the sds caused a 1-2 second vasospasm.After that, there was no difficulty inserting the sds into the intended location prior to deployment.During deployment however, the stent was deployed prior to the intended lesion location.No issues were noted with the deployment and the stent did not deploy prematurely.The stent was noted to be the correct size after deployment, but the stent did not cover the whole lesion; only a portion of the stent was deployed over the intended lesion.Therefore, the sds was removed and the physician deployed another of the same stent to cover the rest of the lesion to complete the procedure.No further patient complications were reported and the patient's status was stable.

• 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: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8111142
• MDR Text Key: 128615296
• Report Number: 2134265-2018-63200
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2022
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0022367412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• 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; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 160