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

Model Number 106524US

Device Problems Malposition of Device (2616); Infusion or Flow Problem (2964)

Patient Problem Cardiac Arrest (1762)

Event Date 01/12/2020

Event Type  Injury  

Manufacturer Narrative

The patient remains on lvad support with no further issues reported.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that patient decompensated overnight with cardiopulmonary arrest on (b)(6) 2020 due to sternal dehiscence and tamponade.Patient was re-cannulated on venous arterial (va) extracorporeal membrane oxygenation (ecmo) with speed adjusted to 3800 rpm to support minimal flow through pump and to serve at lv vent.Chest x-ray showed pump malposition that was due to intrathoracic pressure from tamponade and rotated the pump.Multiple low flow events were observed.Treatment included re-operation, sternal washout, chest open, ecmo for temporary support.Patient was stable with plans for chest closure with pec flap and sternal reconstruction on (b)(6) 2020.No further information was provided.

Manufacturer Narrative

Section a2: correction.Manufacturer's investigation conclusion: a direct relationship between the device and the reported sternal dehiscence and tamponade could not be conclusively determined through this investigation.Furthermore, the report of pump malposition could not be confirmed through this investigation.The account reported that the patient was implanted three weeks ago and decompensated overnight with cardiopulmonary arrest on the morning of (b)(6) 2020.The patient was re-cannulated on venoarterial extracorporeal membrane oxygenation with pump speed adjusted to 3800 rpm to support minimal flow through the pump and to serve at left ventricular vent.A chest x-ray showed pump malposition that likely occurred over the last 24 hours.The system controller event log file showed the pump speed initially set to 5500 rpm.The pump speed was then decreased throughout the log file.By 10:33:28 on (b)(6) 2020, the pump speed was set at 3800 rpm, where it remained for the remainder of the log file.From 09:20:48 through 09:26:56, the flow ranged from 0.0 to 1.0 lpm, resulting in constant low flow alarms.Flow remained above the 2.5 lpm threshold until 09:48:49, when the flow dropped to 2.4 lpm.Transient low flow alarms as well as transient low flow controller fault flags were captured from 09:48:49 until 10:16:03, when flow began to decline.By 10:20:31, low flow alarms were continuous through the end of the log file.During this time (from 10:20:31 to 11:08:01), flow ranged from 0.6 to 2.4 lpm.No additional atypical alarms or trends in pump parameters were captured.The pump appeared to function as intended.It was later reported that the cardiopulmonary arrest was due to sternal dehiscence and tamponade.It was also reported that the pump was malpositioned due to intrathoracic pressure from tamponade and rotated the pump.The patient was treated with re-operation, sternal washout, chest open, and ecmo for temporary support.As of (b)(6) 2020, the patient was stable with plans for chest closure with pec flap and sternal reconstruction on (b)(6) 2020.The patient remains ongoing on vad support and no further complaints were reported.The hm3 ifu lists wound dehiscence as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.The surgical procedures section of the hm3 ifu details how to adjust the pump¿s position.The patient care and management section also contains a subsection entitled ¿blood leak diagnosis¿ which references tamponade as a possible symptom of a potential blood leak.There may be risks associated with performing external chest compression, in the event of cardiac arrest, due to the location of the outflow graft and the presence of ventricular apical anastomosis.Performing external chest compression may result in damage to the outflow graft or the dislodgement of the left ventricular assist device inflow tract.The introduction of the hm3 ifu explains the pump parameters, including pump flow.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.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: 9644674
• MDR Text Key: 177141574
• Report Number: 2916596-2020-00226
• 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: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6605480
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 117