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	Bacterial Infection (1735); Hemolysis (1886); Skin Infection (4544); Lactate Dehydrogenase Increased (4567)
Date of Event	08/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a specific cause of the patient's driveline infection could not be determined.Additionally, a direct correlation between heartmate (hm) ii left ventricular assist system (lvas), serial number (b)(6), and the reported events could not be conclusively established through this evaluation.The submitted log files collectively contained events and data from (b)(6) 2025.No notable alarms or events, or significant fluctuations in pump parameters were captured.The pump appeared to function as intended and operated at or above the lsl for the duration of the file.The patient remains ongoing on hmii lvas, serial number (b)(6).No further related events have been reported at this time.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu), rev.B and the heartmate ii patient handbook, rev.A, are currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including hemolysis, hepatic dysfunction, and infection (local, driveline, pump pocket or pseudo pocket), that may be associated with the use of the heartmate ii left ventricular assist system.Section 6 of the ifu, "patient care and management", also lists infection as a potential late postimplant complication.Section 6, under "anticoagulation", contains information regarding the recommended anticoagulation therapy and international normalized ratio (inr) range, as well as suggested anticoagulation modifications.Furthermore, several sections of the heartmate ii ifu and patient handbook provide care instructions regarding how to prevent infection as well as the suggested responses in the event an infection occurs.The current revision of the ifu and patient handbook can be found on the eifu page of the abbott website.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.
Event or Problem Description
It was reported that the patient was admitted with rising lactate dehydrogenase (ldh) of 1,200.No alarms were noted.Log files captured routine events throughout the log.At this time, there were no plans for computed tomography angiography (cta) or echocardiogram (echo) as the patient was clinically stable and had a history of fluctuating ldh levels.The cause of elevated ldh was determined to be multifactorial, chronic macroangiopathic hemolysis due to the left ventricular assist device (lvad), hepatic congestion from heart failure exacerbation, and ongoing chronic infection.Delafloxacin was given for chronic infection.Ldh continued to trend.The patient was not having any other symptoms at this time.Additional log files showed no unusual events recorded.There were no changes to the infection including source, culture, or symptoms/treatment since (b)(6) 2017, which was the date of onset infection.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 22906879
• Report Number: 2916596-2025-05411
• Device Sequence Number: 12762695
• Product Code: DSQ
• UDI-Device Identifier: 00813024010616
• UDI-Public: (01)00813024010616(17)121231
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

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 Expiration Date: 12/31/2013
• 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: 08/08/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2011
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 133 KG