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	Insufficient Information (4580)
Date of Event	12/01/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Sections a and d: specific patient information and device serial number are documented as unknown.Details are listed in the attached article.Device was implanted at time of event.Section b2: specific death date is documented as unknown.Details are listed in the attached article section b3: date of event has been entered as: 01dec2023 as patients were implanted between nov2014 and dec2023.Author information: aponte camacho, g.M., yuzefpolskaya, m., kurlansky, p., zhao, y., shah, s., colombo, p., sayer, g., naka, y., baranowska, j., reinke, h., & takeda, k.(2025).Guideline directed medical therapy associations with late right heart failure in patients on heartmate 3 support.The journal of heart and lung transplantation, 44(4).Https://doi.Org/10.1016/j.Healun.2025.02.977.Columbia university vagelos college of physicians and surgeons, new york city, ny.Columbia university irving medical center, new york city, ny.New york presbyerian hospital, new york city, ny.Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas) and the reported patient outcomes could not be conclusively established through this evaluation.The serial numbers or other identifying information of the products were not reported and were not able to be determined during the investigation.The current revisions of the instructions for use (ifu) and patient handbook can be found on the eifu page of the abbott website.The heartmate 3 lvas ifu rev.D is currently available.Section 1 of the ifu, ¿introduction¿, lists adverse events, including death, that may be associated with the use of the heartmate 3 lvas.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported through the research article, ¿guideline directed medical therapy associations with late right heart failure in patients on heartmate 3 support.¿ a retrospective, single center study evaluating associations between guideline directed medical therapy (gdmt) and late right heart failure (l rhf) in patients supported with the heartmate 3 (hm3) lvad.This study evaluated late right heart failure (l rhf) in 314 patients supported with the heartmate 3 lvad and assessed associations with guideline directed medical therapy.L rhf occurred in 18.8% of patients and was associated with lower incidence of l-rhf in hm3 supported patients; use of beta blockers, raas inhibitors, and sglt2 inhibitors was protective, while need for amiodarone, diuretics, hydralazine, or pde 5 inhibitors was associated with higher risk.Five-year survival was reduced for l-rhf patient vs no rhf patients, 51.9% vs 78.5%, p< 0.01.

• 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 25280156
• Report Number: 2916596-2026-2917045
• Device Sequence Number: 9777318
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: (01)00813024013266
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/26/2026
• 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