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

Model Number 106524US

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

Patient Problems Stroke/CVA (1770); Death (1802); Right Ventricular Dysfunction (2054); Hemorrhagic Stroke (4417); Heart Failure/Congestive Heart Failure (4446)

Event Date 11/12/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

Related manufacturer report number: 2916596-2020-06045.It was reported that the patient showed signs of worsening right ventricular (rv) dysfunction following pump exchange on (b)(6) 2020.The patient's hemodynamics showed increasing central venous pressure (cvp) and worsening rv dilatation.The decision was made to place centrimag rvad and the patient was centrally cannulated and their chest was closed.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported right ventricle dysfunction, hemorrhagic stroke, and subsequent patient outcome, as well as a direct correlation to heartmate 3 left ventricular assist system (lvas), serial number (b)(4), could not be conclusively determined through this evaluation.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 14oct2020.The current heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) lists right heart failure, stroke, and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system in section 1, ¿introduction¿.Neurological dysfunction is also listed as a potential late postimplant complication in section 6 ¿patient care and management¿.Section 6 entitled ¿patient care and management¿ cautions the user that right heart failure can occur following implantation of the pump and warns that ¿right heart 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¿.This section also outlines the associated treatment options, including rvad placement.Section 6 (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 there is a risk of bleeding.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was additionally reported that the patient suffered a large hemorrhagic stroke.A computed tomography (ct) scan was done to diagnose the stroke.The patient passed away due to stroke and withdrawal of care on (b)(6) 2020.

Manufacturer Narrative

Section b2: additional information; section b5: additional information; section d6: correction; section h1: report type has been corrected: updated from serious injury to death report; section h6: additional information - patient codes; no further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10960457
• MDR Text Key: 219984940
• Report Number: 2916596-2020-05981
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7670573
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEARTMATE 3 LVAS IMPLANT KIT(SN: (B)(4).; HEARTMATE 3 LVAS IMPLANT KIT(SN: (B)(4))
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 54