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

Model Number 26605

Device Problems Failure to Advance (2524); Material Deformation (2976)

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

Event Date 01/29/2024

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 21-feb-2024.It was reported that crossing difficulties and shaft kink occurred.The patient underwent stent implantation of the 90% stenosed target lesion located in the severely calcified and tortuous left carotid artery.After obtaining vascular access via the right femoral artery, a common guidewire and a vertebral angiography catheter were inserted along a vascular sheath.After determining the lesion location, a 14-system guidewire was used and an 8f mach 1 guiding catheter was placed at the internal carotid artery bifurcation opening for support.Following deployment of a filter wire, a 5x20 balloon was advanced for pre-dilatation.An 8.0-29 carotid wallstent was advanced for treatment but failed to cross the lesion.After removal, it was noted that the delivery system at the tip of the stent was curved and could no longer be used.The procedure was completed with another stent.There were no complications reported and the patient status was stable.However, returned device analysis revealed a stent damage.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a carotid wallstent.The device was returned with the stent in the correct position on the delivery system.A visual and tactile examination identified that the sheath of the device and stent were kinked at the same location at approximately 15mm proximal of the tip.This type of damage is consistent with excessive force being applied to the device.No other issues were noted with the delivery system.E1- initial reporter facility name: (b)(6) hospital.E1- initial reporter address 1: (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: 18892908
• MDR Text Key: 337515935
• Report Number: 2124215-2024-15163
• 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
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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: 0031138250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 77 KG