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

Model Number 107801

Device Problems Mechanical Problem (1384); Decreased Pump Speed (1500); Pumping Stopped (1503); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2023

Event Type  Death  

Event Description

It was reported that the patient passed away.They were found down at home.The care providers suspected the pump was the cause as the patient's driveline had known phase to phase damage and was not considered a repair candidate.A review of the log files revealed low flow events on (b)(6) 2023 to (b)(6) 2023.On (b)(6) 2023 at 12:01:44 pm, while connected to battery power, a speed reduction and a pump stopped event were recorded.This event may have been due to a phase to phase short within the driveline.The lowest recorded pump speed during these events were 8500 rpms.This event appears to have lasted approximately 20 seconds.On (b)(6) 2023 2:57:07 pm - 3:55:09 pm, several speed reductions and pump stopped events were recorded while connected to battery power.These events may also have been due to a phase to phase short within the driveline.A driveline disconnect event was recorded on (b)(6) 2023 at 3:55:09 pm.

Manufacturer Narrative

Mfr # 2916596-2016-01569 captured previous short to shield issue.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted log file revealed events consistent with driveline damage, as well as transient low flow events; however, a specific cause for these findings could not be conclusively determined through this evaluation, as the device was not returned for evaluation.Furthermore, a direct correlation between heartmate ii left ventricular assist system (lvas), serial number: (b)(6), and the reported patient outcome cannot be conclusively established through this evaluation.The submitted log file contained events from 25nov2023 ¿ 01dec2023.The log file captured several transient low flow events on 29nov2023 and 30nov2023.Beginning on 01dec2023 at 04:45:43, the low flow events appeared to become more persistent and continued intermittently for the remainder of the log file.The log file also captured several transient pump stop events on 01dec2023 between 12:01:44 ¿ 12:02:04 and 14:57:07 ¿ 15:51:09 with associated low speed advisory/ hazard and low flow hazard alarms.These events were accompanied by elevations in pump power and flow as the pump was unable to maintain the set speed.The associated voltage levels indicated that the pump stoppage events occurred when the system was powered by batteries.Based on previous complaint experience, the events captured in the submitted log file appear consistent with a potential phase to phase driveline issue.The driveline was ultimately disconnected on (b)(6) 2023 at 15:55:09.This appears consistent with the report that the patient expired on (b)(6) 2023.Of note, the timing of the patient's expiration could not be determined through this evaluation.The heartmate ii (hmii) left ventricular assist system (lvas) instructions for use (ifu), rev.C, and patient handbook, rev.C, are currently available.Section 1 of the ifu, "introduction", lists the adverse events that may be associated with the use of the heartmate ii left ventricular assist system, including death.Section 1 of the ifu also provides an explanation of all pump parameters, including pump flow.Section 4 ¿system monitor¿ provides more information regarding all pump parameters and describes situations which may result in a low flow hazard alarm.Section 6 "patient care and management" 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 also cautions that physiological factors that affect the filling of the pump result in reduced pump flows as long as the condition persists.Section 6 of the ifu addresses how to care for the driveline; however, all heartmate ii drivelines have the potential for wire/shield breakdown to occur dependent on duration of use and movement/flexing over time.In addition, section 6 (under "pump performance monitoring") outlines indications of driveline damage as well as how to respond to such events.Section 7 entitled "alarms and troubleshooting" outlines all system controller alarms and the appropriate actions associated with them.The heartmate ii lvas patient handbook contains a section on ¿caring for the driveline.¿ the section entitled ¿alarms and troubleshooting¿ outlines all system controller alarms as well as how to respond to each alarm condition.A section on handling emergencies is also provided.The relevant sections of the device history records for (b)(6) and the driveline, serial number 62608, were reviewed and showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Mfr#: 2916596-2016-01569 captured previous short to shield issue.

• Brand Name: HEARTMATE II 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18445675
• MDR Text Key: 331918805
• Report Number: 2916596-2023-08739
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011996
• UDI-Public: 00813024011996
• 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,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2019
• Device Model Number: 107801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2016
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 62 KG