MAUDE Adverse Event Report: Thoratec Corporation THORATEC® HEARTMATE II®, LVAS IMPLANT KIT; Ventricular (Assist) Bypass

Model Number	107801
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Sepsis (2067); Hypervolemia (2664); Thrombosis/Thrombus (4440)
Date of Event	12/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the article ¿outcome of ventricular assist devices in adults with congenital heart disease ¿ a single center case series¿ was a single-center retrospective cohort study of patients who underwent ventricular assist device (vad) implantation at the mayo clinic between 2003 and 2023.The study described the clinical characteristics and post-operative outcomes of the cohort, while assessing post-operative temporal changes in end-organ biomarkers and hemodynamic indices.Given the high mortality rate of advanced heart failure in adults with congenital heart disease (chd), the investigation aimed to evaluate if vad therapy provides an acceptable palliation or bridge to transplantation despite potential long-term survival limitations.Data on specific indices, including n-terminal pro-hormone brain natriuretic peptide (nt-probnp), the model for end-stage liver disease excluding international normalized ratio (meld-xi), right atrial pressure, and non-systemic ventricular systolic pressure, were tracked pre-implantation and 30 days post-implantation.Of the 11 patients who met the criteria for vad implantation between january 2009 and december 2022 (median age 42 years, 73% males), underlying congenital heart disease (chd) diagnoses included congenitally corrected transposition of great arteries (n=4), transposition of great arteries post atrial switch operation (n=2), fontan palliation (n=2), aortic stenosis (n=2), and coarctation of aorta (n=3).Implanted devices consisted of heartmate-iii (n=6), heartware (n=4), and heartmate-ii (n=1), acting as destination therapy for 7 patients and a bridge to transplant for 4 patients.Following a median cardiopulmonary bypass time of 136 minutes, post-operative assessments revealed no statistically significant changes in biomarkers (¿ nt-probnp -907 "[ -2384; 6706]" pg/ml and ¿ meld-xi -1.30 "[ -3.23; 4.17]") or echocardiographic indices (¿ right atrial pressure -2 "[ -5; 1]") and ¿ nonsystemic ventricular pressure -8 "[-18; 3]" mmhg).Two fontan patients (18%) who required concomitant extracorporeal membrane oxygenation (ecmo) support died of multi-system organ failure prior to hospital discharge.The remaining 9 patients were discharged after a median hospital stay of 39 days, yielding a median vad support duration of 96 weeks.Post-operative complications across the total cohort included sepsis (27%), bleeding (18%), and device thrombosis (9%), with 1 patient requiring a pump exchange at 73 weeks.Additionally, 6 of the surviving patients required at least 1 hospitalization within 90 days due to bleeding, infection, volume overload, or suspected pump dysfunction.Throughout the extended follow-up, 8 of the 9 discharged patients eventually died, primarily from multi-system organ failure (n=7) and hemorrhagic stroke (n=1).The overall survival rates were 91% at 30 days, 64% at 1 year, and 36% at 3 years; when excluding the fontan-ecmo patients, survival rates increased to 100%, 78%, and 44%, respectively.The study presented the largest single center case series of outcomes after vad implantation in adults with chd.The operative mortality was low in patients with biventricular physiology, and 1-year survival was modest, albeit a lower survival compared to heart transplant.There was no significant improvement in biomarkers of end-organ function and hemodynamic indices.Vads are frequently implanted in late terminal stages where end-organ damage is irreversible, emphasizing that earlier intervention and data from a multicenter registry are necessary to refine patient selection strategies.
Additional Manufacturer Narrative
Section a, d: specific patient information and device serial number are documented as unknown.Younis, a., kholeif, z.M., miranda, w.R., connolly, h.M., villavicencio, m.T., dearani, j.A., & egbe, a.C.(2026).100648.Https://doi.Org/10.1016/j.Ijcchd.2025.100648.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• Brand Name: THORATEC® HEARTMATE II®, 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 ; +1(781)852-8207
• MDR Report Key: 50011808
• Report Number: 2916596-2026-2918724
• Device Sequence Number: 10551602
• Product Code: DSQ
• UDI-Device Identifier: 00813024011996
• UDI-Public: (01)00813024011996
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 107801
• Device Catalogue Number: 107801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 07/31/2026
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown