MAUDE Adverse Event Report: CVRX, INC. BAROSTIM NEO; IMPLANTABLE PULSE GENERATOR

Model Number 2102

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

Patient Problems Fatigue (1849); High Blood Pressure/ Hypertension (1908); Pulmonary Edema (2020); Renal Failure (2041); Electrolyte Imbalance (2196); Cardiogenic Shock (2262); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/17/2023

Event Type  Injury  

Event Description

A barostim system was implanted on (b)(6) 2022.On (b)(6) 2023, the patient reported increased shortness of breath and fatigue, and barostim therapy was increased.On (b)(6) 2023, the patient experienced increased shortness of breath.Due to the shortness of breath, the patient was self-dosing with lasix.Labs were performed, and lasix was discontinued due to cariomems numbers.On (b)(6) 2023, the patient was in distress and directly admitted to the intensive care unit due to cardiogenic shock.A right heart catheterization (rhc) was performed, and results showed elevated pulmonary alveolar proteinosis (pap).Inotropes were administered.Thoracentesis was performed on (b)(6) 2023, and 850ml of fluid was removed.Kidney function was reported to be worsening.Lung arterial pressure were indicative of hypovolemia on (b)(6) 2023, and milrinone was discontinued with volume boluses administered.Barostim therapy was decreased from 9.4 mas to 5.0 mas.Dobutamine was administered, and pleural fluid returned.Bilateral chest tubes were placed on (b)(6) 2023, and filling pressures were reported to be low.The patient was hypertensive, and high dose steroids were administered.The patient was positive for perinuclear anti-neutrophil cytoplasmic antibodies (panca), and there was a concern for vaculitis causing renal failure, and dobutamine was discontinued.A renal biopsy was performed and was negative for vaculitis.The patient had their chest tubes removed and were discharged on (b)(6) 2023.As of (b)(6) 2023, the patient was doing well, and a steroid taper was prescribed.The patient still experienced generalized weakness and was referred to cardiac rehab.In the opinion of the physician, the barostim therapy increase on (b)(6) 2023 caused the patient's blood vessels to "over-dilate" which resulted in too much fluid being stored in vasculature.

Manufacturer Narrative

While analysis was unable to be performed as the device was not returned, per the opinion of the physician, the root cause of the event was barostim therapy affecting the patient's blood vessels.The device history and sterilization record for this device serial number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.H6: health effect clinical code 4581: suggested codes are "panca" and "shortness of breath" cvrx id# (b)(4).

Event Description

A barostim system was implanted on (b)(6) 2022.On (b)(6) 2023, the patient reported increased shortness of breath and fatigue, and barostim therapy was increased.On (b)(6)2023, the patient experienced increased shortness of breath.Due to the shortness of breath, the patient was self-dosing with lasix.Labs were performed, and lasix was discontinued due to cariomems numbers.On (b)(6) 2023, the patient was in distress and directly admitted to the intensive care unit due to cardiogenic shock.A right heart catheterization (rhc) was performed, and results showed elevated pulmonary alveolar proteinosis (pap).Inotropes were administered.Thoracentesis was performed on (b)(6)2023, and 850ml of fluid was removed.Kidney function was reported to be worsening.Lung arterial pressure were indicative of hypovolemia on (b)(6) 2023, and milrinone was discontinued with volume boluses administered.Barostim therapy was decreased from 9.4 mas to 5.0 mas.Dobutamine was administered, and pleural fluid returned.Bilateral chest tubes were placed on (b)(6) 2023, and filling pressures were reported to be low.The patient was hypertensive, and high dose steroids were administered.The patient was positive for perinuclear anti-neutrophil cytoplasmic antibodies (panca), and there was a concern for vasculitis causing renal failure, and dobutamine was discontinued.A renal biopsy was performed and was negative for vasculitis.The patient had their chest tubes removed and were discharged on (b)(6) 2023, the patient was doing well, and a steroid taper was prescribed.The patient still experienced generalized weakness and was referred to cardiac rehab.In the opinion of the physician, the patient's comorbidities along with the mechanism of action, including vasodilation, of the barostim therapy and the barostim therapy increase on (b)(6) 2023 exacerbated the retainment of interstitial fluid.

Manufacturer Narrative

While analysis was unable to be performed as the device was not returned, per the opinion of the physician, the patient's comorbidities along with the mechanism of action, including vasodilation, of the barostim therapy and the barostim therapy increase on (b)(6) 2023 exacerbated the retainment of interstitial fluid.Cvrx id#: (b)(4).

• Brand Name: BAROSTIM NEO
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis 55445
• Manufacturer (Section G): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis 55445
• Manufacturer Contact: sarah hicks ; 9201 west broadway avenue; suite 650; minneapolis 55445
• MDR Report Key: 17756732
• MDR Text Key: 323517800
• Report Number: 3007972010-2023-00045
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004432
• UDI-Public: (01)00859144004432(17)240829
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180050
• 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,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2102
• Device Catalogue Number: 100054-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Race: White