MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 106015

Device Problems Mechanical Problem (1384); Low Readings (2460); Infusion or Flow Problem (2964)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

The patient remains ongoing with the lvad device.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 with a previous driveline repair presented to the clinic.Log file submitted revealed low flow events occurring on (b)(6) 2020, (b)(6) 2020, (b)(6) 2020 and (b)(6) 2020.Driveline fault events beginning on (b)(6) 2020 which continue to occur throughout the remainder of the log file; however, there has been no interruption in pump support thus far in the log file.The patient was informed that another driveline repair is not possible.The clinic untwisted the tangled driveline (dl) the best they could.No alarms occurred when the clinic was untwisting the dl.The patient will continue to be monitored closely as the patient is not a pump exchange candidate.No additional information provided.

Manufacturer Narrative

Manufactures investigation conclusion: the patient remains ongoing on heartmate ii lvas.No product is available for investigation.The evaluation of the submitted log files confirmed driveline fault and low flow alarms; however, a specific cause for the alarms cannot be determined through this investigation.The submitted log file contained data spanning from (b)(6) 2020 22:57:08 through (b)(6) 2020 11:24:18.The log file captured a long string of driveline faults from (b)(6) 2020 through (b)(6) 2020.The alarm did not affect the controller¿s ability to operate the pump at the set speed.Transient low flow events were captured on (b)(6) 2020.The faults were captured while the patient was supported by both the power module and battery power.The submitted log file contained data spanning from (b)(6) 2020 20:47:46 through (b)(6) 2021 20:17:20.The log file captured intermittent strings of driveline faults throughout the file.The alarm did not affect the controller¿s ability to operate the pump at the set speed.The faults were captured while the patient was supported by both the power module and battery power.The account reported that the patient was experiencing driveline fault alarms.The customer was informed that another driveline repair was not possible.The customer untwisted the tangled driveline the best they could.No alarms occurred when the customer was untwisting the driveline.The customer will continue to monitor this patient closely.The patient was not a pump exchange candidate.The heartmate ii lvas ifu lists adverse events that may be associated with the use of heartmate ii lvas.The hmii lvas ifu and patient handbook address all visual and audible system alarms, as well as how to respond to each alarm condition.Pump parameters, including speed, power, and flow, are detailed in the introduction section of the hmii ifu.This section explains that pump power is a direct measurement of motor voltage and current; therefore, changes in pump speed, flow, or physiological demand can affect pump power.Also noted, is that device flow and power generally retain a linear relationship at a given speed.However, while power is directly measured by the system controller, the reported flow is estimated, based on power.The alarms and troubleshooting section of the hmii ifu gives an in-depth overview of all alarms, how they are triggered, and how to respond to an alarm(s).A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11065575
• MDR Text Key: 223425546
• Report Number: 2916596-2020-06268
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2017
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 82