MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); Ventricular (assist) bypass

Model Number 106015

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2024

Event Type  malfunction  

Event Description

It was reported that the patient had a vibration feeling in their chest on (b)(6) 2024.Since then, it had increased, and they noticed an increase in pump flow and power.A review of the log file revealed pump power and flow trending upward with spikes noted.The patient was admitted on (b)(6) 2024.Their international normalized ratio (inr) was 2.0.The patient's inr goal was 2.5-3.5 due to prior thrombus history.Log files were sent for review on (b)(6) 2024 to see if there were any improvements in powers with hydration.Log files showed that the pump parameters were stable.It was reported that hydration improved the elevated parameters and that a heparin drip was started.The patient was not symptomatic.An echocardiogram was performed on (b)(6) 2024.The cause of the vibration/elevated parameters was not determined.Log files were sent on (b)(6) 2024.A review of these log files revealed pump power and flow treading upwards with spikes noted.The power and flow had not stabilized.

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 continued to have elevated powers of 12-13 watts on (b)(6) 2024.A small power spike was captured on (b)(6) 2024 and power was stable in the 4-5 watts range.The patient had dark urine on (b)(6) 2024.The patient was admitted on (b)(6) 2024.The patient's lactate dehydrogenase level increased to 1100 units per liter (u/l).A computed tomography (ct) was performed and was negative for thrombus.The patient still had intermittent vibrations coming from the pump.The patient received fluids and a heparin drip to treat the hematuria and elevated ldh.The patient's symptoms resolved.The event log files captured a few instances when power was elevated to 12-13 watts on (b)(6) 2023.A small power spike was captured on (b)(6) 2024 and power had been stable in the 4-5 watts range.

Manufacturer Narrative

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

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18972514
• MDR Text Key: 339256593
• Report Number: 2916596-2024-01478
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 116 KG