MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 106524

Device Problem Partial Blockage (1065)

Patient Problems Hemolysis (1886); Right Ventricular Failure (2055)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

The heartmate 3 lvas was implanted during the momentum 3 clinical trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing momentum 3 trial.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).Approximate age of device ¿ 7 months.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported that the lvad system produced low flow alarms.The patient experienced shortness of breath secondary to anxiety, and was admitted.The following morning the patient was stable.Echocardiogram (echo) did not reveal any device issues, but did reveal right heart dysfunction, and the lvad speed was increased.There was no distinguishable change in left ventricular size with speed changes.Dobutamine and nipride were started.Ct scan with direct contrast revealed little flow coming from the pump.There was concern for outflow graft obstruction, and the patient¿s lactate dehydrogenase (ldh) was 400 u/l.On (b)(6) 2018 ct scan with contrast revealed an obstructed outflow graft.On (b)(6) 2018 it was reported that the patient was still admitted and stable on inotropes.The patient had multiple angiograms to evaluate flow through the pump, all of which were consistent with limited to no flow.The patient was being supported with inotropes and had a pa catheter for hemodynamic monitoring.There were no plans for outflow graft revision unless the patient became unstable.The patient was evaluated for transplant.No additional information was provided.

Manufacturer Narrative

It was initially reported that the device was not available for evaluation.The patient subsequently received a heart transplant and the pump was returned for investigation.The evaluation is not yet complete.

Event Description

On (b)(6) 2018 it was reported that the patient was still inpatient and stable on inotropes.Review of the submitted log file by technical services revealed lvad flow trending downward over time.The lvad speed was changed between 7600 rpm ¿ 9000 rpm.The low flow alarms were reportedly increasing in frequency.On (b)(6) 2018 the patient underwent heart transplant after being upgraded on the transplant list from 1b to 1ab due to outflow graft twisting.The patient¿s heart was explanted with heartmate 3 attached to the left ventricle.The surgeon cut into the bend relief exposing the outflow graft with a visible twist just superior to the blue screw ring.It was reported that the blue screw ring was loose and able to be rotated left and right with slight effort.On (b)(6) 2018, it was reported that the patient was so far stable after transplant.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 7477297
• MDR Text Key: 107030864
• Report Number: 2916596-2018-01596
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• 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: 06/13/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 106524
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 05/01/2018
• Supplement Dates Manufacturer Received: 05/18/2018
• Supplement Dates FDA Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 104