MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS

Model Number 106524

Device Problem Infusion or Flow Problem (2964)

Patient Problems Right Ventricular Dysfunction (2054); Blood Loss (2597)

Event Date 08/23/2018

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

The patient was started on inotropes due to symptomatic low flow and right ventricular dysfunction.Multiple echocardiograms were preformed.Due to poor image quality,the patient underwent right heart catheterization that noted he/she was intravascularly dry.During admission, a mediastinal hematoma was noted.The site reported fluids were increased.No further information was reported.

Event Description

The patient was taken back into the operation room for exploratory surgery for bleeding on (b)(6) 2018.On (b)(6) 2018, the patient had an abnormal swallowing evaluation due to dysphagia post lvad placement.No further information was provided.

Manufacturer Narrative

Section d4: the heartmate 3 left ventricular assist system (lvas) was implanted during the momentum 3 clinical trial, ide# g140113.Fda approval for heartmate 3 lvas was received on (b)(6)2017.The gtin unique device identifier for the commercial heartmate 3 lvas is (b)(4).Section a2, a4, g3: correction manufactuer's analysis conclusion: a direct relationship between the device and the reported events could not be conclusively determined.Furthermore, the report of low flows could not be confirmed as no log files were submitted for review.The patient remains ongoing on vad support.Bleeding, right heart failure, and psychiatric episode are listed in the heartmate 3 instruction for use (ifu) as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.The patient care and management section provides information regarding anticoagulation, including recommended inr values, as well as a subsection entitled ¿right heart failure¿.The introduction of the hm3 ifu explains the pump parameters, including pump flow, pump speed, pulsatility index (pi), and pump power.Per design, when the estimated flow value is calculated at less than 2.5 lpm, a low flow status is posted to the log file.If the flow remains below 2.5 lpm for 10 seconds, a low flow hazard alarm is triggered.The hazard alarms sub-section of the hm3 ifu notes that ¿changes in patient conditions can result in low flow, such as hypertension.¿ the alarms and troubleshooting section explains all system alarms, including low flow alarms, and the recommended actions associated with them.The hm 3 ifu states that if the system detects a pi event, the pump speed will automatically reduce to the low speed limit and slowly ramp back up.Pi events are assumed by the system during cases where there is a sudden and substantial change in pi.Some reasons for pi changes include sudden changes in the patient¿s volume status, arrhythmias, sudden changes in power, and sudden changes in pump speed.The patient remains ongoing on vad support.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 9731962
• MDR Text Key: 182149647
• Report Number: 2916596-2020-00874
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 106524
• Device Lot Number: 6490637
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Weight: 81