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

Model Number 106524INT

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

Patient Problems Hemorrhage/Bleeding (1888); Ischemia (1942); Thromboembolism (2654); Renal Impairment (4499)

Event Date 05/03/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2022 the patient experienced mediastinal bleeding that was treated with blood products and resolved on (b)(6) 2022.On (b)(6) 2022, the patient had reduction of urine output and fluid output.On (b)(6) 2022, the patient had an arterial peripheral thromboembolism (left inferior leg ischemia) that required surgical revascularization.The patient was also experiencing frequent low flow alarms and a threshold of 2.0 liters per minute was requested for the patient.The patient was evaluated and blood pressure and volume intake were optimized; however the alarms did not disappear.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the reported events could not be conclusively established through this evaluation.Evaluation of the submitted parsed log file revealed transient low flow fault flags that were triggered when the estimated flow dropped below the low flow threshold to as low as 1.8 lpm.Of these faults, 14 lasted over 10 seconds and low flow alarms were triggered.A specific cause for these alarms could not be conclusively determined through this evaluation.No other atypical events or alarms were captured, and the pump appeared to function as intended at the set speeds.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu) and the heartmate 3 lvas patient handbook are currently available.Section 1, ¿introduction,¿ lists bleeding, thromboembolic events, and renal dysfunction as adverse events that may be associated with the use of the heartmate 3 lvas.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 4 of the ifu entitled ¿system monitor¿ explains that the low flow hazard alarm is triggered when pump flow is less than 2.5 lpm, the pump has stopped, the pump is not operating properly, or the driveline is disconnected from the system controller.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, such as hypertension.Section 7 entitled ¿alarms and troubleshooting¿ explains all system alarms and the recommended actions associated with them.Heartmate 3 lvas patient handbook, section 5 entitled "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information was received that the low flow alarms resolved with the low flow software upgrade.

• 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: 14596851
• MDR Text Key: 293304849
• Report Number: 2916596-2022-11261
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/12/2023
• Device Model Number: 106524INT
• Device Lot Number: 8185471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2021
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 70 KG