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 Codes	Arrhythmia (1721); Hemorrhage/Blood Loss/Bleeding (1888); Renal Failure (2041); Multiple Organ Dysfunction Syndrome (3261); Syncope/Fainting (4411); Heart Failure/Congestive Heart Failure (4446); Skin Infection (4544)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the heartmate3 (hm3) was associated with bleeding, infection, heart failure (hf) exacerbation, neurological dysfunction, cardiac arrhythmia, device malfunction, anticoagulation adjustment, pre-syncope and syncope, hypotension and hypovolemia, electrolyte abnormalities, renal failure, respiratory distress/failure, and chest pain.The aim of this study was to identify risk factors associated with hospital readmissions among patients with continuous flow -left ventricular assist devices (cf-lvads).This retrospective study evaluated patients implanted with a cf-lvad between february 2011 and march 2021 using prospectively maintained institutional databases.Hospital readmissions within three years post-lvad implantation were dichotomized into heart failure (hf)/lvad-related or non-hf/lvad-related readmissions.A total of 31% pf patient were implanted with hm3.Patients with an hf/lvad-related readmission were more commonly supported with the hvad medtronic, minneapolis, mn, usa) (75.4% versus 57.6%, p=0.014) as opposed to the hm3 lvad (abbott laboratories, chicago, il, usa).This resulted in a final cohort of 204 patients, and 586 readmissions were observed during the study period.Hf- or lvad-related reasons accounted for 436 out of the 586 readmissions.Overall, 138 patients (67.7%) had at least one hf/lvad-related readmission within three years post-lvad implantation.Hf/lvad-related readmissions were mainly for major bleeding (27.8%), major infection (22.2%), hf exacerbation (11.7%), neurological dysfunction (8.0%), cardiac arrhythmia (8%), device malfunction (6%), anticoagulation adjustment (5%), pre-syncope and syncope (4%), hypotension and hypovolemia (4%), electrolyte abnormalities (2%), renal failure (1%), while non-hf/lvad-related readmissions were gastrointestinal disorder (21%), planned procedure ( 19%), endocrine disorder (12%), respiratory distress/failure (6%), chest pain (5%) and trauma (5%).
Additional Manufacturer Narrative
A1: patient information is unknown.D4: device information is unknown.Reference: christos p.Kyriakopoulos, et al.J.Clin.Med.2024, 13, 2869.Https://doi.Org/ 10.3390/jcm13102869 no further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Manufacturer¿s investigation conclusion: a specific cause for the reported infection could not conclusively be determined through this evaluation.A direct correlation between heartmate 3 left ventricular assist systems (lvas) and the reported events could not conclusively be established through this evaluation.The serial number or other identifying information of the product was not reported and was not able to be determined during the investigation.The heartmate 3 lvas ifu,, rev.C, and the heartmate 3 lvas patient handbook, rev.D, are currently available.Section 1 of the ifu, ¿introduction¿, lists bleeding, infection (local and driveline or pump pocket), cardiac arrythmia, neurologic dysfunction, and multiple types of organ failure and dysfunction (respiratory failure, right heart failure, renal failure, hepatic dysfunction) as 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¿ provides the recommended anticoagulation regimen, including international normalized ratio (inr) range, as well as suggested anticoagulation modifications.This section also lists infection, cardiac arrythmia, neurologic dysfunction, and hypovolemia as potential late postimplant complications that may be associated with the use of the heartmate 3 lvas.Furthermore, several sections of the 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.

• 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: 21129702
• Report Number: 2916596-2025-00131
• Device Sequence Number: 15192878
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: (01)00813024013266
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Literature
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: 12/16/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/25/2025
• 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: Life Threatening
• Patient Sex: Unknown