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

Model Number 26665

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ischemia Stroke (4418)

Event Date 04/18/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced stroke.On (b)(6) 2023, the patient underwent surgery and an 8x29, 5f, 135cm carotid wallstent was implanted in the carotid artery to regain blood flow.Three days later, the patient was discharged.However, the patient suffered another stroke two days after the discharged and was admitted back.It was then determined that the implanted stent failed, resulting in placement of two additional stents.No further patient complications were reported.

Manufacturer Narrative

E1: initial reporter facility name: (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: 17316782
• MDR Text Key: 319012198
• Report Number: 2124215-2023-34703
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08714729781202
• UDI-Public: 08714729781202
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26665
• Device Catalogue Number: 26665
• Device Lot Number: 0030583646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• 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 Outcome(s): Hospitalization; Required Intervention; Other
• Patient Sex: Male