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

Model Number 106524US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Hemorrhage/Bleeding (1888); Liver Damage/Dysfunction (1954); Pleural Effusion (2010); Renal Failure (2041); Heart Failure/Congestive Heart Failure (4446); Respiratory Insufficiency (4462)

Event Date 01/18/2022

Event Type  Injury  

Event Description

It was reported that the patient was implanted with a heartmate 3 left ventricular assist device (lvad) on (b)(6) 2022.Post-operatively the patient went into right ventricular heart failure with symptoms of dyspnea.On (b)(6) 2022 the patient developed respiratory failure and was treated with inotropes and nitic oxide.The patient was intubated and had a tracheostomy.An echocardiography revealed worsening hepatic dysfunction and worsening renal dysfunction.In response to the post-operative complications the patient had a right ventricular assist device (rvad) implanted.This rvad was removed on (b)(6) 2022.Their baseline creatinine (cr) was 1.5 and it had trended up to 2.72.On (b)(6) 2022 the patient required blood products due to acute blood loss and anemia.On (b)(6) 2022 the patient had pleural effusion related to an underlying liver dysfunction.

Manufacturer Narrative

No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was noted that the right heart failure led to permanent impairment of body structure/function and unplanned in-patient and prolonged hospitalization.It was reported that the respiratory failure resolved on (b)(6) 2022, the bleeding resolved (b)(6)2022, the pleural effusion resolved (b)(6) 2022, the renal dysfunction resolved (b)(6) 2022, and the right heart failure resolved (b)(6) 2022.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported event could not be conclusively determined through this evaluation and a direct correlation to the heartmate 3 left ventricular assist system (hm3 lvas), serial number (b)(6), could not be conclusively determined.Multiple requests for additional information were issued to the customer but no further information was provided.The patient remains ongoing with heartmate 3 left ventricular assist system, serial number (b)(6).The relevant sections of the device history record for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu), is currently available.Section 1, ("introduction") lists potential adverse events that may be associated with the use of the hm3 lvas, including right heart failure, respiratory failure, renal dysfunction, hepatic dysfunction, bleeding, and cardiac arrhythmia.Section 6, (¿patient care and management¿), lists potential late postimplant complications that may be associated with the use of the hm3 lvas, including cardiac arrhythmia.The ifu also provides information regarding anticoagulation, including the recommended international normalized ratio (inr) values, as well as provides information regarding postoperative patient care, including how to prevent and control infection.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient passed away on (b)(6) 2022.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events and subsequent patient outcome could not be conclusively determined through this evaluation.Multiple attempts were made to obtain additional and clarifying information from the customer regarding the reported events and the pump's return status; however, no further information was provided, and the pump has not been returned to date.If hm3 lvas, serial number (b)(6), is returned at a later date, this investigation may be reopened to include the evaluation of the device.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu), is currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including multiple types of organ failure and dysfunction (respiratory failure, right heart failure, renal failure, and hepatic dysfunction), bleeding, cardiac arrhythmia, and death, that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 of the ifu, ¿patient care and management¿, lists arrhythmia as a potential late postimplant complication.This section, under "anticoagulation", also outlines the recommended anticoagulation regimen, including inr range for patients using the heartmate 3 lvas, as well as the suggested anticoagulation modifications in the event that there is a risk of bleeding.Section 6 of the ifu, under ¿right heart failure¿, states that patients may develop right ventricular failure during or shortly after implant and outlines the associated treatment options, including placement of a right ventricular assist device (rvad).Additionally, section 6, under ¿caution!¿, explains that right ventricular dysfunction, especially when combined with elevated pulmonary vascular resistance, may limit the effectiveness of the left ventricular assist system due to reduced filling of the pump.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13605200
• MDR Text Key: 287923348
• Report Number: 2916596-2022-00839
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/18/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8240056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Death; Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 128 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White