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

Model Number 106524US

Device Problems Decreased Pump Speed (1500); Infusion or Flow Problem (2964)

Patient Problems Pulmonary Edema (2020); Multiple Organ Failure (3261); Thrombosis/Thrombus (4440)

Event Date 10/06/2023

Event Type  Injury  

Event Description

It was reported that the patient had an outflow obstruction that required surgical intervention on (b)(6) 2023.A computed tomography scan (ct) had confirmed the obstruction was on the outside of the graft at the bend relief.The patient also showed symptoms of pulmonary and venous congestion, organ failure, and was poorly perfused.After the surgery, the patient still experienced low flows.The patient's status improved, but they remained in the intensive care unit (icu).A log file analysis observed a backup battery fault that occurred on (b)(6) 2023, and low flow alarms occurred on (b)(6) 2023.

Manufacturer Narrative

No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that the patient had an outflow graft obstruction that required surgical intervention on (b)(6) 2023.A computed tomography (ct) scan was conducted which confirmed a clot formation on the outside of the outflow graft underneath the outflow graft bend relief.The patient was poorly perfused and had signs of pulmonary and venous congestion and organ failure due to the obstruction.Log files revealed low flow alarms on (b)(6) 2023.Following the procedure, the patient initially continued to experience lower pump flow values than expected.The patient was improving but remained intubated in the intensive care unit (icu).

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported extrinsic outflow graft obstruction could not be confirmed.A specific cause for the reported obstruction could not be conclusively determined through this evaluation.Additionally, review of the submitted log files confirmed low flow alarms.A specific cause for the reported events as well as a direct correlation between the alarms the outflow graft obstruction could not be conclusively determined through this evaluation.The controller event log files contained events from 06oct2023 through 11oct2023 and 30oct2023.Multiple low flow alarms were captured on (b)(6) 2023.Some of the low flow events captured on 06oct2023 were associated with elevated pi values.The pump appeared to function as intended at the set speed.The patient remains ongoing on heartmate (hm) 3 left ventricular assist system (lvas), serial number mlp-(b)(6) and no further related events have been reported at this time.The relevant sections of the device history records for mlp-(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 patient handbook, are currently available.Section 1 of the ifu, ¿introduction¿, addresses all pump parameters, including pump speed, flow, and pulsatility index (pi).In reference to pi, the ifu explains that pi calculation represents cardiac pulsatility and pi values typically range from 1 to 10.In general, the magnitude of the pi value is related to the amount of assistance provided by the pump.Higher values indicate more ventricular filling and higher pulsatility (i.E.The pump is providing less support to the left ventricle).Section 4 of the ifu, ¿system monitor¿, describes the pump flow display and the hazard alarms.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.Section 4 also explains that changes in patient condition can result in low flow.Section 5 of the ifu, ¿surgical procedures¿, outlines considerations for pump placement and provides instructions regarding the preparation, installation, and orientation of the sealed outflow graft.Section 5, under "attaching the sealed outflow graft to the pump," instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.Section 5 of the ifu, under "preimplant procedures" and "implant procedures" cautions the user: "the sealed outflow graft must not be kinked or positioned where it could abrade against a pump component or body structure" and "stretch the sealed outflow graft completely prior to measuring and cutting the graft to the appropriate length." section 5 of the patient handbook, ¿alarms and troubleshooting¿, and section 7 of the ifu, ¿alarms and troubleshooting¿, provides information on all system alarm conditions as well as the appropriate actions associated with each condition.A section on ¿handling emergencies¿ is also provided in the patient handbook.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: 17957893
• MDR Text Key: 325951572
• Report Number: 2916596-2023-07419
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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: 11/05/2022
• Device Model Number: 106524US
• Device Lot Number: 7720355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• 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; Life Threatening
• Patient Sex: Male
• Patient Weight: 85 KG