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

Device Problem Fracture (1260)

Patient Problem Aneurysm (1708)

Event Date 03/01/2022

Event Type  Injury  

Event Description

It was reported that stent fracture and aneurysm occurred.The patient underwent a thrombus recovery and carotid artery stenting for acute occlusion of the 100% stenosed left internal carotid artery due to internal carotid artery dissection.A carotid wallstent was advanced and implanted.Immediately after the procedure, right hemiplegia and sensory impairment improved.The magnetic resonance imaging (mri) findings one and two months after the procedure did not change.Three months later, angiography showed stent fracture and aneurysm formation.Postoperative computed tomography showed that the oversized stroma was in contact with and compressed by the internal carotid artery, suggesting that eagle's syndrome was the cause.Stent assisted coil embolization was performed.Two months later, it was confirmed that there was no recurrence of the aneurysm or re-damage of the stent.

Manufacturer Narrative

Date of event: used the first day of the month of the bsc aware date since no event date provided.

• 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
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14166548
• MDR Text Key: 289734319
• Report Number: 2134265-2022-03892
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 58 YR
• Patient Sex: Male