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

Model Number 106524US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Thromboembolism (2654); Hemorrhagic Stroke (4417)

Event Date 01/18/2022

Event Type  Injury  

Event Description

It was reported that the patient presented with persistent low flows ~1.8-2-2.Echo obtained revealed a large clot in aortic root which is likely causing low flows.The patient has been maintained off anticoagulation due to cerebellar hemorrhage and has 50-60 percent compression of outflow graft.Submitted log file captured multiple low flow events on (b)(6) 2022.The calculated flow appears to have fluctuated below the alarm threshold of 2.5 lpm.Additional information requested but not provided.Related manufacturer report number 2916596-2021-01177.

Manufacturer Narrative

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

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 presented with persistent low flows ~1.8-2-2.Echo obtained revealed a large clot in aortic root which is likely causing low flows.The patient has been maintained off anticoagulation due to cerebellar hemorrhage and has 50-60 percent compression of outflow graft.Submitted log file captured multiple low flow events on (b)(6) 2022.The calculated flow appears to have fluctuated below the alarm threshold of 2.5 lpm.Additional information requested but not provided.Related manufacturer report number 2916596-2021-01177.

Manufacturer Narrative

Initial report added related manufacturer reference # 2916596-2021-01177 on b5 to refer to previous report related to the compression of the outflow graft previously reported in feb2021.Manufacturer's investigation conclusion: review of the submitted log files confirmed low flow alarms.Although a specific cause for the low flow alarms could not be conclusively determined, it was reported by the account that the patient had a clot in the aortic root which was believed to have contributed to the low flow events.A direct correlation between the device and the reported cerebellar hemorrhage and aortic root clot could not be conclusively established through this evaluation.The submitted system controller event log file captured intermittent low flow alarms on (b)(6) 2022.No notable alarms or events were captured.The pump appeared to operate as intended at the set speed.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6).No further related events have been reported at this time.The heartmate 3 lvas instructions for use (ifu), rev.C, is currently available.Section 1, "introduction," lists stroke, bleeding, and thromboembolism as adverse events that may be associated with the use of heartmate 3 lvas.Although the infection reported was deemed to not be device-related, infection is also listed as an adverse event.Section 4, ¿system monitor,¿ explains that the low flow hazard alarm occurs when pump flow is less than 2.5 liters per minute (lpm).A 10-second delay is imposed between the detection of the low flow status and the activation of the associated audio and visual indicators on the system controller.Changes in patient conditions can result in low flow.Section 6, ¿patient care and management¿ (under ¿anticoagulation¿), provides the recommended anticoagulation regimen, including international normalized ratio (inr) range, as well as suggested anticoagulation modifications.Section 7, ¿alarms and troubleshooting,¿ explains all system alarms and the recommended actions associated with them.The heartmate 3 lvas patient handbook, rev.D, also outlines all system controller alarms, as well as how to respond to each alarm condition.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.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: 13524193
• MDR Text Key: 286019456
• Report Number: 2916596-2022-00459
• 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: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/21/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6935865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2019
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White