MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G247

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

Patient Problems Dyspnea (1816); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Malaise (2359); Pericardial Effusion (3271)

Event Date 02/28/2024

Event Type  Death  

Event Description

It was reported that the patient experienced a small pericardial effusion and hypotension, immediately following a cardiac resynchronization therapy defibrillator (crt-d) placement.The crt-d system was placed on the right side of the patient due to left breast cancer.The patient reported malaise and dyspnea post procedure.A chest x-ray was performed, and no pneumothorax was noted.An echocardiogram was then performed and a slight detachment of the posterior aspect of the pericardium was observed and there was no tamponade.Blood loss from the device pocket was also observed during the implant procedure.This patient was transferred to the intensive care unit for a blood transfusion and further care.This crt-d system remains in-service.No additional adverse patient effects were reported.Additional information was provided, it was reported that the patient passed way during the night, it was thought to be due to the underlying coagulopathy.The physician does not believe that the death was related to any boston scientific products.The crt-d system remains implanted in the patient and there are no plans on explanting the system.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18919046
• MDR Text Key: 337842772
• Report Number: 2124215-2024-15971
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 304252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death