MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524US

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

Patient Problem Right Ventricular Dysfunction (2054)

Event Date 01/05/2020

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient experienced dizziness and multiple pi (pulsatility index) events.It was suspected that the pi (pulsatility index) events were caused by volume, orthostatic blood pressure changes, right ventricular dysfunction, and small lvidd (left ventricular internal diameter).The patient had mild right ventricular dysfunction prior to being implanted with an lvad (left ventricular assist device), however it was now moderate-severe.It was unclear if the patient's right ventricular dysfunction worsened related to the vad or due to progressive heart failure.The patient was given intravenous fluids and started back on midodrine with symptomatic improvement.The patient was sent home with a planned routine follow-up as an outpatient.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas and the reported events could not be conclusively determined through this evaluation.The account submitted log files for review.The system controller event log file contains data from (b)(6) 2020 at 8:24:41 through (b)(6) 2020 at 8:00:04.The log file was comprised of routine power cable disconnects and pi events.Transient pi events were observed throughout the log file, resulting in momentary decreases in speed per design.The pump appeared to function as intended.The patient remains ongoing on heartmate 3 lvas.The hm3 lvas ifu lists right heart failure as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.It also states ¿right heart failure can occur following implantation of the pump.Right ventricular dysfunction, especially when combined with elevated pulmonary vascular resistance, may limit the effectiveness of the left ventricular assist system due to reduced filling of the pump.¿ no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 9648018
• MDR Text Key: 177142584
• Report Number: 2916596-2020-00239
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7093825
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 04/23/2020
• Supplement Dates FDA Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 90