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

Model Number	106524US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Multiple Organ Dysfunction Syndrome (3261)
Date of Event	03/01/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Sections a and d: specific patient information and device serial number are documented as unknown.Device was implanted at time of event.Date of event has been entered as 01march2022 since the date collection occurred between january 2021 and march 2022.Zhuldyz nurmykhametova et al., j extra corpor technol 2024, 56, 10¿15, 2024 https://doi.Org/10.1051/ject/2023048 department of perfusiology and assisted circulation laboratory, national research cardiac surgery center, astana 010000, kazakhstan.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported through the research article titled ¿preliminary report of extracorporeal blood purification therapy in patients receiving lvad: cytosorb or jafron ha330¿ identifying that heartmate 3 (hm3) is associated elevated proinflammatory cytokines, kidney injury, postoperative bleeding, and death due multiorgan failure.This is a retrospective study that reviewed prospectively collected data from 15 patients who underwent left ventriculat assist device (lvad) hm 3 implantation at a single tertiary care center between january 2021 and march 2022.Intraoperatively, patients were single randomized 1:1:1 to three groups: group 1, patients who received cytosorb therapy (n = 5; installed in the cardiopulmonary bypass (cpb) circuit); group 2, patients who received jafron ha330 (n = 5; installed in the cpb circuit); and control group 3, patients who did not receive filter (n = 50) usual care, neither cytosorb nor jafron during cpb.Data were obtained from a prospectively collected institutional lvad database that included detailed information on patient demographics, baseline clinical characteristics, laboratory and hemodynamic parameters, intraoperative variables, and postoperative outcomes.The patients were followed up for 30 days after hospital discharge.To evaluate the impact of cytokine adsorption on additional clinically relevant parameters, it was determined interleukin (1alfa,6,8), procalcitonin (pct), n-terminal pro-b-type natriuretic peptide (nt-probnp), c-reactive protein (crp), leukocyte, tumor necrosis factor alpha (tnf-a) levels before and after the onset of ha as a measure of hemodynamic stabilization in all groups.All the patients in the three groups had elevated levels of inflammatory markers in the perioperative and immediate postoperative periods.After 72 h of intensive care, the levels of blood inflammation markers tended to decline.No in-hospital mortality was observed.Over a median follow-up of 1 year between the groups, there were no survival differences (80%, 100%, and 80%).In both cases, the cause of death was multiorgan failure.The mean icu stay duration (1, 2, and 2 days) and hospital stay duration (32, 29 and 24 days) were not significantly different between the cytosorb, jafron, and control groups.In-hospital major adverse events, such as acute kidney injury, the need for hemodialysis, and postoperative bleeding, were similar in all groups.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas) and the reported multisystem organ failure (msof) and subsequent patient outcome could not be conclusively determined through this evaluation.The device history records could not be reviewed as the heartmate 3 device serial numbers as well as other specific case/patient information, are not available.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including multiple types of organ failure and dysfunction (respiratory failure, right heart failure, renal failure, hepatic dysfunction) and death, that may be associated with the use of the heartmate 3 left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
• Common Device Name: 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: 20193864
• Report Number: 2916596-2024-06031
• Device Sequence Number: 7546506
• Product Code: DSQ
• UDI-Device Identifier: 00813024010616
• UDI-Public: (01)00813024010616
• Combination Product (Y/N): N
• Initial Reporter Country: KZ
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown