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

Model Number 26605

Device Problems Positioning Failure (1158); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2024

Event Type  malfunction  

Event Description

It was reported that stent struts damage occurred.Vascular access was obtained via the left femoral artery and whole brain angiography revealed about 70% stenosis in the target lesion located in the extremely tortuous left internal carotid artery (ica).After placing a guide catheter, a 0.014 guidewire was advanced into the lesion followed by another catheter.The guidewire was removed, and a filter wire was advanced.Following pre-dilatation, an 8.0-29 carotid wallstent was advanced over the filter wire.However, after reaching the lesion, the sheath could not be withdrawn and the stent could not be deployed.After removal, it was noted that the stent struts had been deformed.The procedure was completed with a 9x40 carotid wallstent.There were no complications reported and the patient status was stable.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).

Event Description

It was reported that stent struts damage occurred.Vascular access was obtained via the left femoral artery and whole brain angiography revealed about 70% stenosis in the target lesion located in the extremely tortuous left internal carotid artery (ica).After placing a guide catheter, a 0.014 guidewire was advanced into the lesion followed by another catheter.The guidewire was removed, and a filter wire was advanced.Following pre-dilatation, an 8.0-29 carotid wallstent was advanced over the filter wire.However, after reaching the lesion, the sheath could not be withdrawn and the stent could not be deployed.After removal, it was noted that the stent struts had been deformed.The procedure was completed with a 9x40 carotid wallstent.There were no complications reported and the patient status was stable.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.A visual examination found the stent of the device to be fully deployed from the device.The deployed stent was not returned for analysis.A visual and tactile inspection identified no kinks or damage to the delivery system.A visual examination identified no issues with the tip of the device.This concludes the product analysis.

• 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: 18758828
• MDR Text Key: 336968323
• Report Number: 2124215-2024-08114
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0030183325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2022
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 68 KG