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

Model Number 106524US

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Embolism (1498)

Event Date 07/19/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022 at 11:02, the flow rapidly dropped to zero within around 5 seconds.The flow remained at 0 lpm for five hours, the pump power dropped from 4 w to around 2-3 w and the pulsatility index (pi) value was in the 2-3 range.The patient was admitted to the hospital and had a computed tomography angiography (cta) to check for any obstructions.A system controller exchange was performed, but did not resolve the flow issue.The patient was found to have a pulmonary embolism (pe) and after a thrombectomy was done there was a sudden return to flow.Additional log file review found the reported low flow hazard alarms as well as a limited amount of data showing the estimated flow returned.No abnormal pump faults were seen in the log file.It was noted that there was insufficient information for a periodic log file review.Additional log files were submitted as harmonic compensation events were recorded.The event log file was also populated with harmonic compensation events and some motor instability events.This data indicated that there may be something on the rotor causing the instability.Another set of log files was sent for review, which indicated that the internal faults for harmonic compensation and motor instability had resolved.The last of these internal faults occurred on (b)(6) 2022 at 08:08.The pump then appeared to be running normally.The patient was doing well.Log files were sent for review of the rotor instability and it was noted that the patient remained stable with no left ventricular assist device (lvad) alarms.The overall pump function looked good and it appeared to be functioning as intended.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacture¿s investigation conclusion: review of the submitted log files confirmed a low flow hazard alarm associated with a complete loss of flow.Although a specific cause for this event could not be conclusively determined through this evaluation, the account indicated that the patient had been off anticoagulation medication and that their flow had a sudden recovery following the removal of a pulmonary embolism.A direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported pulmonary embolism could not be conclusively established through this evaluation.Additionally, pump thrombus could not be confirmed through this evaluation as no images were submitted for analysis and the device remains in use; however review of the submitted log files confirmed a pump power and flow elevation, as well as left ventricular assist device (lvad) fault flags, that appeared consistent with material, such as a thrombus, being ingested into the pump and contacting the rotor.The submitted controller and lvad event log files contained data from (b)(6) 2022 through (b)(6) 2022, per the timestamps.A low flow hazard alarm associated with a complete loss of flow was captured on (b)(6) 2022.Lvad fault flags associated with rotor instability were recorded shortly after the onset of the low flow alarm.Approximately six hours later, a partial recovery in estimated flow was observed, consistent with the reported flow recovery following the patient¿s thrombectomy procedure.Additional lvad fault flags associated with rotor instability were captured between (b)(6) 2022 and (b)(6) 2022 following the partial recovery of estimated flow.During this timeframe, a transient elevation in pump power and flow was captured.The lvad fault flags resolved approximately one and a half hours after this elevation.On (b)(6) 2022, the patient¿s estimated flow fully recovered to their baseline range.No other notable events or alarms were captured.The pump appeared to function as intended at the set speed.Based on complaint history and similarly reported events, information captured within the submitted log files is consistent with pump ingestion of a foreign material; however, a specific cause for the elevated power and flow values, as well as the lvad fault flags, could not be conclusively determined through this evaluation.The patient remains ongoing on heartmate 3 lvas, serial number mlp-025712, with no further issues reported at this time.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) and the heartmate 3 lvas patient handbook are currently available.Section 1 of the ifu, ¿introduction¿, lists peripheral thromboembolic events and pump thrombosis as adverse events that may be associated with the use of the heartmate 3 lvas.This section also addresses all pump parameters, including pump power and flow.Section 4, ¿system monitor¿, describes the pump flow display and the hazard alarms.The ifu states that 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.This section also explains that changes in patient condition can result in low flow.Section 6 of the ifu, ¿patient care and management¿, contains information regarding the recommended anticoagulation therapy and international normalized ratio (inr) range.This section also lists thromboembolism as a potential late postimplant complication.Section 7 of the ifu, "alarms and troubleshooting", and section 5 of the patient handbook, "alarms and troubleshooting", address all system alarm conditions as well as the appropriate actions associated with each condition.Furthermore, section 8 of the patient handbook, ¿handling emergencies¿, also provides examples of emergencies and the proper actions to take in the event an emergency occurs.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specification.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that as of (b)(6) 2022 the patient was doing fine.The patient was off anticoagulants.There were no recent changes to pump parameters.No symptoms of thrombus were observed.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15122750
• MDR Text Key: 296788825
• Report Number: 2916596-2022-12509
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

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: 12/01/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7911582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 08/31/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 133 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White