MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Septic Shock (2068)

Event Date 03/24/2021

Event Type  Death  

Event Description

It was reported that the patient had an episode overnight from (b)(6) 2021 on hemodialysis (hd) where their eyes rolled backwards.The patient also reportedly shook for about one minute.The event resolved without intervention.The patient was alert and appropriate the morning of (b)(6) 2021.A log file review was requested.Technical services reviewed the log file and observed 128 pulsatility index (pi) events on (b)(6) 2021 from 00:18:16 to 6:31:55.Additional information reported that the patient was on ecmo/continuous renal replacement therapy (crrt) prior to vad implant, so renal failure was pre-existing.The patient was still inpatient and critically ill.The plan of care was unclear, but it was noted that the patient has had a prolonged hospitalization post-implant.It was later reported that the patient passed away due to severe septic shock on (b)(6) 2021.No autopsy was performed.The device was not explanted.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) 3 left ventricular assist system, serial number (b)(6) and the reported event could not be conclusively established through this evaluation.Additionally, a specific cause for the patient's severe septic shock could not be conclusively determined through this evaluation.The controller event log file contained data from (b)(6) 2021.The pump operated at a stable speed for the duration of the log file with multiple pulsatility index events captured along with routine power exchanges.There were no other notable events or alarms captured in this file.The device appeared to be functioning as intended.It was reported through patient outcome that the patient passed away due to severe septic shock on (b)(6) 2021.There was no autopsy performed and the device was not explanted for evaluation.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 3 left ventricular assist system (lvas) instructions for use (ifu) lists sepsis and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Care instructions regarding preventing infection are included in several sections of the ifu, including in section 6 "patient care and management" (under "caution!", "caring for the driveline exit site", and "controlling infection").Section 6 also provides suggested responses in the event of infection.Although it was reported that the patient's renal failure existed prior to lvad implant, renal dysfunction is listed as an adverse event that may be associated with the use of the hm3 lvas.The heartmate 3 lvas patient handbook provides care instructions regarding preventing infection in several sections, including section 4 ¿living with the heartmate 3¿ (under ¿caring for the driveline exit site¿).The patient handbook instructs the patient to call their hospital contact immediately if any signs of infection are noticed.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11749594
• MDR Text Key: 248082333
• Report Number: 2916596-2021-02336
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7425374
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 65 YR
• Patient Weight: 72