MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, LVAS IMPLANT KIT, US, EP; Ventricular (assist) bypass

Model Number	103695
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Hypovolemia (2243); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	12/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to an outside hospital's emergency department for a one-day history of increased shortness of breath, productive cough, malaise, and chills.The patient was transferred and admitted to the heart failure service for further workups.Although no alarms were reported or seen in the interrogation, the patient presented with acutely more pulsatility index (pi) events in the last 24 hours of admission without a known cause.An echocardiogram and hemolysis laboratory studies were completed.The log files were submitted for review.The event log captured routine events.There was an increase of pi events noticed but the ventricular assist device (vad) and the peripheral equipment was functioning as intended.Echo results showed depressed left ventricular function, no aortic insufficiency, mild mitral regurgitation, and moderate tricuspid regurgitation.Lactate dehydrogenase (ldh) was stable at 277 compared to 287 two weeks prior.No clinical findings of hemolysis were present.The patient's symptoms were determined to be caused by mild hypervolemia and respiratory viral rhinovirus.The patient was discharged home on a slightly higher diuretic dose.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a direct correlation between heartmate ii left ventricular assist system (lvas), serial number (b)(6), and the reported events could not be conclusively established through this evaluation.Review of the submitted log file confirmed the reported pulsatility index (pi) events; however, a specific cause for the events could not be conclusively determined through this evaluation.The submitted log file contained data from (b)(6) 2025 through (b)(6) 2025.Several pi events were captured throughout the file.No other notable events were captured, and the pump appeared to function as intended.The patient remains ongoing on heartmate ii lvas, (b)(6), with no further issues reported at this time.The current revisions of the ifu and patient handbook can be found on the eifu page of the abbott website.The heartmate ii lvas ifu, is currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events that may be associated with the use of the heartmate ii lvas.This section also addresses pump parameters, including pulsatility index (pi).Section 4 of the ifu, ¿heartmate touch communication system¿, states that pi events are assumed by the system during cases when there are sudden and substantial changes in the pulsatility index.These events may be initiated for reasons other than true pi events, including sudden changes in a patient¿s volume status, arrhythmias, sudden changes in power, and sudden changes in pump speed.Section 5 of the ifu, "surgical procedures", warns that moderate to severe aortic insufficiency must be corrected at the time of device implant.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE II®, LVAS IMPLANT KIT, US, EP
• 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: 24027475
• Report Number: 2916596-2026-00157
• Device Sequence Number: 16088459
• Product Code: DSQ
• UDI-Device Identifier: 00813024010616
• UDI-Public: (01)00813024010616(17)120430
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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 Expiration Date: 04/30/2012
• Device Model Number: 103695
• Device Catalogue Number: 103695
• 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: 12/30/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2009
• 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: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 94 KG