MAUDE Adverse Event Report: CVRX, INC. BAROSTIM NEO; CAROTID SINUS LEAD

Model Number 1036

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

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 06/26/2023

Event Type  Death  

Event Description

A barostim implant occurred on (b)(6) 2023.The patient had a previously implanted crt icd and was 100% paced.There was not a crm representative available during the implant, so a magnet was placed over the crt icd and external defibrillation pads were placed.The procedure began at approximately 3:20-3:30 with no issues.When mapping began at 3:50, the patient's blood pressure was 98/59/88.All mapping positions were tested, and the electrode was placed with verification after two sutures were performed.The patient's blood pressure was 77/58/82.The cvrx representative discussed with anesthesia that verification could be skipped if there was a concern regarding the patient's blood pressure.The anesthesiologist reported that it was okay to proceed as usual.At 4:00, blood pressure was 74/55/82, and pressors were administered.The electrode continued to be sutured in place.At 4:16, anesthesia reported the patient's blood pressure had dropped into the 60's.An attempt was made to manually squeeze the iv bag, but it was reported there was difficulty as the fluid was not going in.The surgeon stopped suturing and stepped away so the iv could be checked.Compressions were started.When compressions were halted, blood pressure dropped, so compressions were continued, and defibrillation was performed.The patient passed away.

Manufacturer Narrative

The serial number of the cvrx ipg utilized in this procedure was (b)(6).The results of the investigation are inconclusive at this time, and the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.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.Cvrx id# (b)(4).

Event Description

A barostim implant occurred on (b)(6) 2023.The patient had a previously implanted crt icd and was 100% paced.There was not a crm representative available during the implant, so a magnet was placed over the crt icd and external defibrillation pads were placed.The procedure began at approximately 3:20-3:30 with no issues.When mapping began at 3:50, the patient's blood pressure was 98/59/88.All mapping positions were tested, and the electrode was placed with verification after two sutures were performed.The patient's blood pressure was 77/58/82.The cvrx representative discussed with anesthesia that verification could be skipped if there was a concern regarding the patient's blood pressure.The anesthesiologist reported that it was okay to proceed as usual.At 4:00, blood pressure was 74/55/82, and pressors were administered.The electrode continued to be sutured in place.At 4:16, anesthesia reported the patient's blood pressure had dropped into the 60's.An attempt was made to manually squeeze the iv bag, but it was reported there was difficulty as the fluid was not going in.The surgeon stopped suturing and stepped away so the iv could be checked.Compressions were started.When compressions were halted, blood pressure dropped, so compressions were continued, and defibrillation was performed.The patient passed away.The family did not request an autopsy, and the physicians were unwilling to discuss the event.

Manufacturer Narrative

The results of the investigation are inconclusive at this time, and the site is unwilling to provide further information on the event.Based on the information received, the cause of the reported event could not be conclusively determined.Cvrx id# (b)(4).

• Brand Name: BAROSTIM NEO
• Type of Device: CAROTID SINUS LEAD
• Manufacturer (Section D): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer (Section G): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer Contact: sarah hicks ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445
• MDR Report Key: 17384410
• MDR Text Key: 319627433
• Report Number: 3007972010-2023-00034
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)241011
• 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: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1036
• Device Catalogue Number: 100063-212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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): Death
• Patient Age: 76 YR
• Patient Sex: Male