MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 106015

Device Problem Obstruction of Flow (2423)

Patient Problems Death (1802); Thrombus (2101); Obstruction/Occlusion (2422)

Event Date 12/28/2020

Event Type  Death  

Manufacturer Narrative

The results/method/conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient passed away on (b)(6) 2020.The patient underwent a heartmate ii to heartmate ii exchange off bypass on (b)(6) 2020.A subcostal incision extending past the midline was made to access the pump.The team was able to disengage the old heartmate ii pump without any issues.The new heartmate ii was placed and the speed was turned on at 6000 rpms, increased to 7000 rpms, increased to 8000 rpms with flows in the 5¿s and powers of 4.5-5.At that time there was no flow going through device noted on echo or no forward flow for the de-airing needle to bleed out.Mean arterial pressures (maps) were controlled at 60-75.The vad speed was increased to 8400 rpms (patient's baseline speed entering operating room) with no flow going through inflow noted on transesophageal echocardiogram (tee) and nothing exiting de-airing needle.The flows were on the higher side at 8400 rpms with flow at 6-6.5 and with powers at 5.6.Shortly after increase of speeds to 8400 rpms clot formation noted on tee, large clot entering left atrial through the mitral valve.At that time hemodynamics became unstable and chest compressions were started.The patient was placed on bypass.Due to amount of down time and clotting of the left atrial/left ventricle the team decided to withdraw care.The lvad (left ventricular assist device) pump was turned off and the patient was closed.Prior to implant of the new heartmate ii, the wet test was performed per protocol with no power spikes noted and the power was within normal limits.The pump was handed up onto the field fully primed.The heartmate ii was connected on the outflow graft side first and the outflow graft was back-bled and then connected to the inflow cannula side.Only the pump body was replaced.Hemodynamics were stable throughout the connection.Pis (pulsatility index) remained low from 1.5-2.0 up to 8400 rpms.After the patient was fully placed on bypass, on full support, heartmate ii parameters were as followed : speed 8000 rpms, flows 3.2, pis 1.5-1.9, and powers 3.1-3.5.It was unable to be attempted to go back up on speed due to severe clotting noted on tee.Log file reviewed of the pump exchange.The log file captured the pump preparation, and then the pump was started at 6000 rpms, then to 8400 rpms, and ran at 8000 rpms until the pump was intently stopped.The power was at 3.2 watts and the flow was 2.4 lpm for approximately 20 minutes, running at 8000 rpms.Manufacturer report number of exchanged pump: 2916596-2020-06507.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct relationship between the device and the reported peripheral thromboembolism, right heart failure, and patient outcome could not be conclusively determined through this evaluation.Additionally, evaluation of the patient¿s submitted log files confirmed low flow alarms; however, a direct cause for the alarms could not be conclusively determined through this evaluation.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) lists peripheral thromboembolic event and right heart failure as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.The patient care and management section of the ifu outlines indications of thrombus and how to respond to such events.This section also discusses anticoagulation, including recommended international normalized ratio (inr) values.The ifu also states that the low flow hazard alarm will be triggered when pump flow is less than 2.5 liters per minute (lpm) and explains that changes in patient conditions can result in low flow.The alarms and troubleshooting section describes the actions to take in the event of a low flow alarm.Review of the device history records showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped to the customer on 05nov2018.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11175526
• MDR Text Key: 226990874
• Report Number: 2916596-2021-00117
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2021
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6689947
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEARTMATE II LVAS IMPLANT KIT.; HEARTMATE II LVAS IMPLANT KIT.
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 67 YR
• Patient Weight: 53