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 Problems Stroke/CVA (1770); Thromboembolism (2654); Ischemia Stroke (4418)

Event Date 04/06/2022

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

It was reported that the patient's log file was sent for review.A review of the log files revealed a low flow event on (b)(6) 2022 at 0546.This low flow event had the flow rate drop to zero after which it recovered back to the 3 lpm range following volume resuscitation and one dose of epinephrine; the intensivist's report did not find any filling issues.This low flow event lasted for about 29 seconds.There were also rotor instability events indicating that the rotor was having issues maintaining levitation.Several low flow events occurred on (b)(6) 2022 from 0549-0552 where the calculated flow was about 2.5lpm but was not sustained long enough to trigger the audible alarm.Throughout this event, pump speed and power remained the same while the patient's pulsatility index (pi) increased.It was reported that the patient suffered an acute ischemic stroke secondary to device ingestion of thrombus, but was able to follow commands.The patient was treated with intravenous anticoagulation.

Manufacturer Narrative

Section a4: patient privacy laws prohibit the release of private patient information and date of birth should have been removed from the previous report.Manufacturer's investigation conclusion: the report of device thrombosis could not be confirmed through this evaluation as no photos or images were submitted and the pump remains in use.The account indicated that the reported ischemic stroke was suspected to be caused by an ingested thrombus.The controller event log file captured 25 low flow fault flags resulting in six low flow hazard alarms on 06apr2022.The calculated average flow dropped to as low as 0.0 lpm on 06apr2022 at 05:46:14.The account indicated that the events were likely related to a suspected device thrombus.The lvad event log file captured rotor noise faults between 05:49:31 and 05:52:45 on 06apr2022.Rotor noise ranged from 12-148 um during the rotor instability events, and the estimated flow was captured below the 2.5 lpm threshold intermittently throughout the file.No other atypical events were captured.Based on complaint history and similarly reported events, the data captured in the log file is potentially consistent with an ingested device thrombus, however, a specific cause for the low flow and rotor instability events cannot be conclusively determined.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6).No product is available for investigation.The heartmate 3 lvas ifu, rev.C, lists pump thrombosis as an adverse event that may be associated with the use of heartmate 3 left ventricular assist system.Section 6 entitled ¿patient care and management¿ lists thromboembolism as a potential late postimplant complication.Section 6 also contains information regarding the recommended anticoagulation therapy and inr range.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on 25feb2022.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 (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: 14186677
• MDR Text Key: 289868295
• Report Number: 2916596-2022-10536
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

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: Health Professional
• Device Expiration Date: 12/15/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8351473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 07/08/2022
• Supplement Dates FDA Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2022
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 78 KG