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

Model Number 106015

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Skin Infection (4544); Lactate Dehydrogenase Increased (4567)

Event Date 06/21/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient had rising lactate dehydrogenase (ldh) levels.A review of the log files found low voltage hazard events on battery power on (b)(6) 2022 at 19:47 - 19:59 due to the batteries being near depleted and both power leads being disconnected causing no external power alarms until fully charged batteries were connected.On (b)(6) 2022, 08:52 - 10:46 there were low flow events noted, the flow recovered into the 3-4 liters per minute (lpm) range and there were no further events noted in the remainder of the log.The rising ldh was believed to be caused by suspected pump thrombosis.The patient had recent infections which were believed to potentially have contributed to the thrombosis.There were no recent changes to pump parameters or diagnostic testing done.The patient was transitioned to comfort care and ultimately expired on (b)(6) 2022 due to end stage systolic heart failure.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of suspected thrombus could not be confirmed as no product was returned for evaluation.A direct correlation between the heartmate ii lvas, serial number (b)(6), and the reported elevated events could not be conclusively established through this evaluation.Evaluation of the submitted log file revealed a persistent low flow hazard alarm that occurred on 21jun2022 at 08:52:23 to 10:46:07 when the flow fell below the low flow threshold of 2.5 lpm to a consistent 2.4 lpm.By 11:56:17 on 21jun2022, the flow returned to normal parameters for the remainder of the log file.A specific cause for the low flow alarms could not be conclusively determined through this evaluation.No product is available for investigation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii lvas instructions for use (ifu) and the heartmate ii patient handbook are currently available.Section 1 of the ifu, ¿introduction¿, lists hemolysis, device thrombosis, and death as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system.Section 1 and section 6 of the ifu, ¿patient care and management¿, outline indications of pump thrombosis and how to respond to such events.Section 6, under ¿anticoagulation¿, provides information regarding the recommended anticoagulation therapy and inr range, as well as suggested anticoagulation modifications.Heartmate ii lvas ifu section 1 "introduction" provides an explanation of all pump parameters, including pump flow.Section 4 ¿system monitor¿ provides more information regarding all pump parameters and also describes situations which may result in a low flow hazard alarm, including changes in patient conditions such as hypertension.Section 4 also provides information on reviewing the event history on the system monitor.Section 6 "patient care and management" (under "pump performance monitoring") explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling, explains that pump flow is estimated from pump power, and addresses assessing pump flow.Section 6 (under "postoperative patient care") also cautions: "physiological factors that affect the filling of the pump, such as hypovolemia or postural hypotension, results in reduced pump flows as long as the condition persists.Pump flows are not restored to normal unless such conditions are treated." section 7 ¿alarms and troubleshooting¿ describes all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.Heartmate ii lvas patient handbook section 5 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.This document instructs the user that in the event of a low flow hazard alarm, call your hospital contact immediately for diagnosis and instructions.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 (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: 15069718
• MDR Text Key: 296284669
• Report Number: 2916596-2022-12192
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/27/2021
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 7370688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2020
• 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): Death
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American