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

Device Problem Premature Activation (1484)

Patient Problems Transient Ischemic Attack (2109); Vascular Dissection (3160); Ischemia Stroke (4418); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 05/01/2009

Event Type  Injury  

Manufacturer Narrative

B3: date of event: between may 2009 and december 2020 hajiyev, k; hellstern, v; cimpoca, a; wendl, c; bazner, h; henkes, h; von gottberg, p; (2022).Carotid artery stenting in patients with symptomatic and asymptomatic stenosis: in-hospital clinical outcomes at a single neurovascular center.Journal of clinical medicine, 11, 2086.Https://doi.Org/10.3390/jcm11082086.

Event Description

It was reported that there was an accidental deployment and adverse events reported with the use of wallstents, requiring intervention.The 7/40 carotid wallstent was selected for use in several carotid artery stenting (cas) procedures to treat patients with symptomatic and asymptomatic carotid artery stenosis during the course of this study.During one procedure, the stent was accidentally deployed, resulting in an iatrogenic dissection.The median intervention time was 33 minutes, and the median x-ray exposure time was 19.1 minutes.Eleven patients exhibited residual stenosis of greater than 50%, which was re-diluted in a later session.During some procedures, five patients developed internal carotid artery (ica) dissections, three patients were diagnosed with distal embolization as documented in the final angiogram.Two patients exhibited transient ischemic attacks (tias), where new-onset cerebral ischemia was not observed.Twenty-three patients developed non-disabling strokes.During a median follow-up of eight months, 101 patients developed in-stent restenosis, or in-stent thrombosis.Eighty-three of these patients required follow-up treatment.Three-hundred and sixty patients underwent magnetic resonance imaging (mri) examinations following cas that revealed silent diffusion-weighted imaging microlesions.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC; 300 boston scientific way; marlborough MA
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18339556
• MDR Text Key: 330659816
• Report Number: 2124215-2023-70491
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention