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

Model Number 26605

Device Problem Difficult to Advance (2920)

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

Event Date 03/28/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2022.It was reported that difficulty advancing and difficulty tracking over the wire occurred.The patient underwent sterilization and right femoral vein puncture.The target lesion was located in the carotid artery.The physician advanced guidewire vascular sheath, a non-boston scientific (bsc) guidewire , and a vertebral artery catheter.After reaching the internal carotid artery, a coronary angiogram (cag) was done which showed the target lesion.The non-bsc guidewire was then replaced and a 8f guiding at the arterial bifurcation to support carotid.Subsequently, a 8.0-21 carotid monorail stent was then prepared and pushed into the intracranial intermediate tube; however, the resistance was encountered and the device was failed to go through.Considering the supportive nature of this intermediate tube, the procedure proceeded normally and was completed with another of same product.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed stent detach.

Manufacturer Narrative

Device evaluated by mfr.: carotid wallstent monorail 8.0-21 was returned for analysis.This carotid device is recommended for use with a 0.014 (0.36mm) guidewire as per carotid wallstent instruction for use (ifu).During the product analysis a boston scientific 0.014 filterwire was successfully inserted through this device with no resistance experienced.The guidewire used by the customer was not returned for analysis.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.The device was received with the stent deployed from the delivery system.The deployed stent was not returned for analysis.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15161653
• MDR Text Key: 304890542
• Report Number: 2134265-2022-07942
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0027291290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 52 KG