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 Muscle Weakness (1967); Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Date 04/02/2024

Event Type  Injury  

Event Description

It was reported that the patient developed increased left extremity weakness and intra-stent thrombosis, requiring additional device intervention.An 8.0-29 carotid wallstent stent was selected for stent implantation.On (b)(6) 2024, the patient underwent angioplasty due to severe stenosis in the initial segment of the right internal artery.However, the initial segment of the right carotid artery was still severely stenosed after spherical dilation, which affected blood flow.After stent implantation, the angioplasty of the c1 segment of the right carotid artery was satisfactory, with residual stenosis of about 20% and rapid blood flow in the distal vessel, and the patient's symptom was significantly improved.On (b)(6) 2024, the patient developed increased left extremity weakness and intra-stent thrombosis.It was noted that the patient was not adequately treated with antiplatelet before procedure, and new thrombosis in carotid stent caused by antiplatelet drugs and others could not be ruled out.Therefore, carotid artery occlusion was re-opened again, and tirofiban antiplatelet therapy was given after procedure, it was improved after thrombectomy.No further patient complications were reported.

Manufacturer Narrative

E1 - initial reporter address 1: no.(b)(6).

Event Description

It was reported that the patient developed increased left extremity weakness and intra-stent thrombosis, requiring additional device intervention.An 8.0-29 carotid wallstent stent was selected for stent implantation.On (b)(6) 2024, the patient underwent angioplasty due to severe stenosis in the initial segment of the right internal artery.However, the initial segment of the right carotid artery was still severely stenosed after spherical dilation, which affected blood flow.After stent implantation, the angioplasty of the c1 segment of the right carotid artery was satisfactory, with residual stenosis of about 20% and rapid blood flow in the distal vessel, and the patient's symptom was significantly improved.On (b)(6) 2024, the patient developed increased left extremity weakness and intra-stent thrombosis.It was noted that the patient was not adequately treated with antiplatelet before procedure, and new thrombosis in carotid stent caused by antiplatelet drugs and others could not be ruled out.Therefore, carotid artery occlusion was re-opened again, and tirofiban antiplatelet therapy was given after procedure, it was improved after thrombectomy.No further patient complications were reported.It was further reported that on (b)(6) 2024 the patient underwent a cerebral angiography, percutaneous endovascular thrombectomy, and stent implantation in the right internal carotid artery c1 segment under local anesthesia.A right common carotid artery angiogram was performed which revealed an occlusion in the stent at the beginning of the right internal carotid artery, with a forward blood flow modified treatment in cerebral infarction (mtici) grade of 0.A non-bsc suction catheter was introduced into the right internal carotid artery c4 and c3 segments using a guide wire, and a large amount of thrombus was extracted through negative pressure suction.The right common carotid artery angiogram showed a filling defect in the stent at the beginning of the right internal carotid artery, with a dissection at the distal end of the stent.The right internal carotid artery c2-c7 segments and the right anterior cerebral artery were clearly visualized, as well as the right middle cerebral artery m1 segment trunk and its branches.A 9.0x40mm carotid wallstent stent was implanted into the distal end of the right internal carotid artery c1 segment using a micro-guidewire.The stent completely covered the stenosis and thrombus segment.The residual stenosis was approximately 20%, and the forward blood flow was unobstructed (mtici grade 3).The stent delivery system was withdrawn, and a 5.0x18mm non-bsc stent was implanted in the distal end of the right internal carotid artery c1 segment dissection using a micro-guidewire, completely covering the dissection.After 10 minutes of observation, the right common carotid artery angiography revealed satisfactory angioplasty of the right internal carotid artery c1 segment with a residual stenosis of approximately 20%.The right internal carotid artery c1-c7 segment, the right middle cerebral artery m1 segment trunk, the upper and lower trunk, and the distal branches of the blood vessels were all unobstructed and clearly visible.The surgery was concluded, and there were no patient complications reported.

Manufacturer Narrative

Initial reporter address 1: no.(b)(6).

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19176552
• MDR Text Key: 340975197
• Report Number: 2124215-2024-23788
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0032699370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 04/28/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2023
• 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): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male