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

Model Number 106524US

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

Patient Problems Death (1802); Fall (1848); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Ischemia Stroke (4418)

Event Date 01/20/2021

Event Type  Death  

Event Description

It was reported that the patient was admitted after collapsing at home for an unknown reason.The patient was intubated and appeared to have experienced a hypotensive event resulting in catastrophic anoxia with little hope for recovery.The patient was noted to have low flow alarms at the time of collapse.The patient has a history of non-compliance.The event log contained 6 sustained low flow hazard events on (b)(6) 2021.The calculated flow appeared to have fluctuated near the alarm threshold of 2.5 lpm.No abnormal alarms or events were recorded in the rest of the log file.A carotid angiogram and a ct was performed on the patient's head and neck.The patient expired on (b)(6) 2021 from a presumed ischemic stroke.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system, serial number (b)(6), and the reported events (ischemic stroke, death, and patient condition) cannot be conclusively determined through this investigation.Low flow alarms were confirmed via the submitted log file data; however, a specific cause for the change in pump parameters cannot be conclusively determined through this investigation.The controller event log file contained data spanning from (b)(6) 2021 at 10:24:41 to (b)(6) 2021 at 09:42:52, per the timestamp.Numerous low flow events were captured on (b)(6) 2021, spanning from 10:25:32 through 11:10:02, when the estimated pump flow was calculated to be below the threshold of 2.5lpm.A total of 6 low flow events persisted for at least 10 seconds, activating low flow alarms.No other notable alarms were recorded, and the pump appeared to have been operating as intended.The account communicated that heartmate 3 left ventricular assist system, serial number (b)(6), had been operating as intended and would not be returned for evaluation as no autopsy was performed.The heartmate 3 left ventricular assist system instructions for use, rev.C, is currently available.Section 1 lists stroke and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 4 describes the pump flow display (4-13 through 4-15) and the hazard alarms (4-19 and 4-32).The instructions for use states that the low flow hazard alarm will be triggered when pump flow is less than 2.5lpm and explains that changes in patient conditions can result in low flow.Section 6 contains information regarding the recommended anticoagulation therapy and international normalized ratio range.Section 7 describes the actions to take in the event of a low flow alarm (7-7 and 7-11).The relevant sections of the device history records were reviewed and showed no deviation from manufacturing or quality assurance specifications.The implant kit shipped on (b)(6) 2020.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: 11313579
• MDR Text Key: 231354828
• Report Number: 2916596-2021-00342
• 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: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/25/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7412130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 52 YR
• Patient Weight: 59