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

Model Number 106524US

Device Problem Decreased Pump Speed (1500)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient's pump speed was changed from 6000 rpm to 7200 rpm, and that the speed was very labile.Their rpm's stayed mostly in the low 6000's and would go up infrequently to the target speed.The echocardiogram (echo) was negative and showed signs of appropriate unloading with left ventricular decompression, aortic valve closure, etc.The patient was to be sent home after having their speed changed from 7200 rpm to 7000 rpm, but that morning the patient's speed ended up doing the same thing and was again labile in the low 6000 rpm to 7000 rpm range.Log files were submitted for review.Log files captured 126 pulsatility index (pi) event's on (b)(6) 2023.Log files also captured that the average speed of the pump was around 6300 rpm with their target speed being 7000 rpm.It was noted that the highest low speed limit possible was 6000 rpm, which cannot be adjusted.Therefore, every time a pi event was trigged the speed would drop down to 6000 rpm and go back up to 7000 rpm.If a pi event was trigged again while the pump was returning to the fixed speed it would drop back down to 6000 rpm and repeat until the cause of the pi event was corrected.There were no other unusual events recorded in the log file event history.The mechanical circulatory system (mcs) equipment is operating as intended.It was noted that the patient's mean arterial pressure (map) were slightly elevated, but consistently at 90 mmhg for the 3 pervious readings.The patient was otherwise asymptomatic and hemolysis labs were stable.

• 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: 18372971
• MDR Text Key: 331178441
• Report Number: 2916596-2023-08470
• 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
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/21/2022
• Device Model Number: 106524US
• Device Lot Number: 7214357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2019
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 126 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White