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

Model Number 106524US

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Thrombosis (2100); Ventricular Tachycardia (2132); Thrombosis/Thrombus (4440); Lactate Dehydrogenase Increased (4567)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had elevated lactate dehydrogenase (ldh).The patient's log files were reviewed and they had multiple low flow alarms with high pulsatility index (pi) events on (b)(6) 2020.The cause of the low flow alarms was due to ventricular tachycardia (vt) and hypotension.After these events resolved the low flows and pi events resolved.The device was operating as intended.The cause of the elevated ldh was likely due to thrombus on the aortic root as well as left main that was noted on left heart catheterization.The patient was on a heparin drops bridge to warfarin.They had a stent placed in the left anterior descending (lad, interventricular) artery.Overall ldh was improving but remained elevated.The patient was not a candidate for pump exchange and the site was discussing care with the patient's family.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the log files provided by the account confirmed low flow alarms.Although a specific cause for these findings could not be conclusively determined through this evaluation, the account reported that the alarms were caused by the patient¿s ventricular tachycardia and hypotension.A direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events could not be conclusively determined through this evaluation.Additionally, a specific cause for the patient¿s infection could not be conclusively determined through this evaluation.The controller event log file contained data from 16:37:27 on (b)(6) 2020 through 08:00:18 on (b)(6) 2020, per the timestamps.Transient low flow fault flags were captured on (b)(6) 2020 when the estimated flow dropped below the low flow threshold of 2.5 lpm, to a range of 2.3-2.4 lpm.These faults resulted in 8 low flow hazard alarms on (b)(6) 2020, lasting between 1 and 9 seconds, each.The remaining faults did not last long enough to trigger low flow hazard alarms.Despite the observed events, the pump appeared to function as intended at the set speed.The patient remained ongoing on heartmate 3 lvas, serial number (b)(6), until (b)(6) 2021 when the patient ultimately expired due to events unrelated to the lvas.The pump was not returned 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 implant kit was shipped on 27aug2018.The heartmate 3 lvas instructions for use (ifu), and the heartmate 3 lvas patient handbook, are currently available.Section 1 of the ifu, ¿introduction¿, lists cardiac arrhythmia and arterial non-central nervous system (cns) thromboembolism as potential adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 of the ifu, ¿patient care and management¿, also lists arrhythmia and thromboembolism as potential late postimplant complications.Additionally, section 6, under ¿anticoagulation¿, provides the recommended anticoagulation regimen, including the inr range, as well as suggested anticoagulation modifications.Section 1 of the ifu also addresses all pump parameters, including pump flow.Section 4, ¿system monitor¿, describes the pump flow display and the hazard alarms.This ifu states that the low flow hazard alarm will be triggered when pump flow is less than 2.5 lpm and explains that changes in patient conditions, such as hypertension, can result in low flow.Section 5 of the patient handbook, "alarms and troubleshooting", and section 7 of the ifu, "alarms and troubleshooting", address all system alarm conditions as well as the appropriate actions associated with each condition.Additionally, although the patient¿s infection was not device related, the ifu lists infection (local, driveline, and pump pocket) as an adverse event that may be associated with the use of the heartmate 3 lvas.Furthermore, several sections of the hm3 ifu and patient handbook provide care instructions regarding how to prevent infection as well as suggested responses in the event of infection.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was communicated that the patient had clostridium difficile (c-diff) which resulted from the patient taking antibiotics.

• 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: 11012252
• MDR Text Key: 221555976
• Report Number: 2916596-2020-05866
• 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: 02/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6585078
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Weight: 56