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); High Readings (2459)

Patient Problems Neurological Deficit/Dysfunction (1982); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  Injury  

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 was admitted to the hospital awaiting an orthotic heart transplant.The patient was having elevated powers and flows occurring simultaneously at intermittent intervals.The patient also suffered a neurological event on (b)(6) 2020.Power elevations that occurred on (b)(6) 2020 were captured due to pi events.The patient underwent a heart transplant on (b)(6) 2020.

Event Description

On (b)(6) 2020, the patient underwent a pump exchange and did not receive a heart transplant.

Manufacturer Narrative

Section g3: previous report inadvertently left blank.Correction: feb 11, 2021.Manufacturer's investigation conclusion: elevated power and flow events were confirmed in the evaluation of the submitted log file; however, a specific cause for the events cannot be determined through this evaluation.A direct correlation between the device and the reported neurological event could not conclusively be established through this investigation.The submitted log file contained data from (b)(6)2020 16:29:46 through 10:08:15.Elevated power events of 10.4 watts and 11.6 watts were captured on (b)(6) 2020, respectively.Flow reached 11.9 and 11.6 lpm during these events, respectively.Prior to and after these events, the pump appeared to function as intended and no other unusual alarms or events were captured.A specific cause for the changes in pump parameters could not be conclusively determined through this evaluation.At the time of the reported event, the patient was admitted awaiting orthotic heart transplant and had been having elevated powers and flows.The patient also suffered a neurological event.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient underwent a pump exchange to (b)(6) on(b)(6) 2020.(b)(6) was returned and evaluated under manufacturer report number 2916596-2020-06467.The heartmate ii lvas ifu provides an explanation of each of the pump parameters (including pump power and flow) in sections 1 "introduction" and 4 "system monitor".Section 1 of the ifu, ¿introduction¿, lists neurologic dysfunction as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system.Section 6, ¿patient care and management¿, also lists neurologic dysfunction as a potential late postimplant complication.Section 1 (under "explanation of parameters") explains that device power is a direct measurement of pump motor voltage and current.Changes in pump speed, flow, or physiological demand can affect pump power.Abrupt changes in power should be evaluated for cause.In addition, 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.Since the flow displayed on the system controller is a calculated value, it becomes imprecise at the low and high ends of the linear power-flow relationship.Section 4 ¿system monitor¿ cautions that no single parameter is a surrogate for monitoring the clinical status of the patient, and the changes in all parameters should be considered when assessing any clinical situation.Section 4 also addresses pi events as well as potential causes.Section 6 "patient care and management" (under "pump performance monitoring") addresses assessing pump flow and explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.The relevant sections of the device history records for (b)(6) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The lvas kit shipped on 30sep2016.No further information was provided.The manufacturer is closing the file on this complaint.

• 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: 11065436
• MDR Text Key: 223405786
• Report Number: 2916596-2020-06094
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 57 YR
• Patient Weight: 93