MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP; VENTRICULAR (ASSISST) BYPASS

Model Number 103696

Device Problems Pumping Stopped (1503); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 02/21/2022

Event Type  Death  

Event Description

Elderly female with history of chronic combined systolic and diastolic heart failure s/p hm2 lvad who comes in for vad alarms this evening.She was admitted due to transient pump stoppages.She underwent an external driveline repair the next day, however the excised drive did not show any wire breakage, indicating that the underlying hardware issue was not fixed.She was discharged with rescue medication should her pump stop at home.She was seen in the vad clinic a few days later by where she was made dnr/dni.Earlier this evening, she started to have recurrence of pump alarms for pump stoppage.They escalated in frequency and right before 8 pm, the longest pump stop was a couple of minutes long.Our vad coordinator was called and she came to the emergency department with her family.In the emergency room, the pump function has returned to normal.Her blood pressure is normal and she denies any symptoms.Our vad coordinator and i had an extensive discussion regarding the nature of the hardware failure and the lack of ability to predict or fix a pump stoppage.The family does not appear to be comfortable taking care of her at home given high risk for pump stoppage, however she is not ready to be admitted to the hospital for comfort care.She is brought into the hospital for further care planning in the setting of vad alarms.Hospital course: patient was getting settled in the room after admission.At 11:40 pm the lvad alarmed for pump stoppage.I was called to the bedside.On arrival the patient was somnolent with mildly increased work of breathing.Iv ativan and iv morphine ordered.At this point the vad alarm had been ongoing for 11 min without any return of pump function.This likely reflected a terminal pump stop.I recommended that we disconnect the vad power source to allow us to focus on her comfort without alarms.The lvad was disconnected from power with the bedside nursing team.Icd confirmed to be off by most recent device interrogation.Comfort care orders placed.Patient died at 0010.Patient had phase to phase short of external driveline with attempted external driveline repair.Unfortunately, this intervention did not work.Patient was not a candidate for a full pump exchange as risks greatly outweighed benefits.

• Brand Name: THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 4550 norris canyon rd; san ramon CA 94583
• MDR Report Key: 14999672
• MDR Text Key: 295781403
• Report Number: 14999672
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 103696
• Device Catalogue Number: 103696
• Device Lot Number: 111599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2022
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 28835 DA
• Patient Sex: Female
• Patient Weight: 108 KG