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

Model Number 26605

Device Problems Failure to Advance (2524); Defective Device (2588)

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

Event Date 07/06/2023

Event Type  malfunction  

Event Description

It was reported that -a profile problem occurred.The 80% stenosed target lesion with a bend of greater than 90 degrees but less than 120 degrees was located in the non-calcified distal end of the left internal carotid artery ostium.An 8.0-36 carotid wallstent was advanced for treatment.However, during introduction, the device could not cross the vessel angulation as the distal end of the stent system was rather stiff and straight the entire time.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported, and the patient status was stable.

Manufacturer Narrative

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

Manufacturer Narrative

E1- initial reporter address 1: (b)(6).E1- initial reporter phone: (b)(6).Device evaluated by manufacturer: carotid wallstent monorail 8.0-36 was received for analysis.A visual examination found the stent of the device to be fully constrained in the correct position on the device.A visual and tactile inspection identified no kinks or damage to the shaft of the device.A visual examination identified no issues with the tip of the device.

Event Description

It was reported that -a profile problem occurred.The 80% stenosed target lesion with a bend of greater than 90 degrees but less than 120 degrees was located in the non-calcified distal end of the left internal carotid artery ostium.An 8.0-36 carotid wallstent was advanced for treatment.However, during introduction, the device could not cross the vessel angulation as the distal end of the stent system was rather stiff and straight the entire time.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported, and the patient status was stable.

• 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: 17392793
• MDR Text Key: 319792506
• Report Number: 2124215-2023-37111
• 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,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• 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: 0031156985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 60 KG