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

Model Number	106524US
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 6% of hf/lvad-related readmissions were for device malfunction.
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: the report of device malfunctions could not be conclusively determined through this evaluation.A specific cause for this event could not be conclusively established.The literature review entitled, ¿hospital readmissions in patients supported with durable centrifugal-flow left ventricular assist devices¿ was received.It identifies that heartmate (hm) 3 is associated with device malfunction.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 heartware ventricular assist device (hvad) (75.4% versus 57.6%, p=0.014) as opposed to the hm3 lvad.This resulted in a final cohort of 204 patients, and 586 readmissions were observed during the study period.Heart failure (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 device malfunction (6%).No product was evaluated under this complaint.The heartmate 3 device serial numbers, as well as other specific case/patient information, are not available.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 device malfunctions as potential events that may be associated with the use of heartmate 3 left ventricular assist system.The hm3 ifu and patient handbook also instruct the user to call their hospital contact if they think, for any reason, that any portion of the equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.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: 21129841
• Report Number: 2916596-2025-00207
• Device Sequence Number: 7677064
• 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?: No
• Is this a Product Problem Report?: Yes
• 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: 02/13/2025
• 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
• Patient Sex: Unknown