MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 106016

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

Patient Problems Hemolysis (1886); Pneumonia (2011); Septic Shock (2068); Bronchial Hemorrhage (4456)

Event Date 04/27/2021

Event Type  Death  

Event Description

It was reported that the patient expired on (b)(6) 2021 from multi-organ failure.The patient was on extracorporeal membrane oxygenation (ecmo) support pre-operative and had a complicated post-operative with airways bleeding, repeated pneumonia, and renal insufficiency requiring renal replacement therapy.On (b)(6) there were increased inflammatory markers with hemolysis.An echocardiography was performed with ramp test for left ventricular assist device (lvad) dysfunction.The patient deteriorated under septic shock despite maximal dosage of vasopressors.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of heartmate ii lvas, serial number (b)(4), confirmed a thrombus formation in the rotor inlet section and inlet stator.Additionally, a specific cause for the reported events, as well as a direct correlation to heartmate ii lvas, serial number (b)(4), could not conclusively be determined through this evaluation.(b)(4) was returned with the driveline fully intact.The sealed inflow conduit (inlet elbow, flex section, and inlet extension) were returned attached to the inlet port.The sealed outflow graft and outflow graft bend relief were returned attached to the outlet elbow secured by the outflow graft collar.The outlet elbow was returned attached to the outlet port.Upon disassembly of the returned pump, examination of the proximal side of the inlet rotor section and distal side of the inlet stator revealed a dark red laminated deposition surrounding the rotor inlet bearing ball and inlet stator bear cup.The two depositions appeared to have the same composition.The darker areas of denaturation indicate that the thrombus was present during support of the patient.The origin and exact duration of time that the deposition was present during patient support could not conclusively be determined through this evaluation.Examination of the outlet stator revealed a red, soft deposition that was not well adhered to the outlet stator.Due to the lack of lamination and denaturation the deposition was likely not present during support of the patient.The origin of the deposition could not conclusively be determined through this evaluation.The observed depositions and thrombus formations could have contributed to the reported hemolysis.Upon removal of the observed depositions, the device was cleaned.The pump's bearings, rotor, and blood-contacting surfaces were then examined under a microscope and no anomalies were observed.Electrical continuity testing of the driveline revealed no discontinuities or shorts.The pump was reassembled and functionally tested under normal operating conditions using a mock circulatory loop.The data retrieved from that testing revealed normal pump power consumption and pressure values, comparable to what was recorded during the manufacturing process and the device functioned as intended.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The lvas kit was shipped on 08aug2018 the heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of this ifu lists hemolysis, renal failure, bleeding, infection, device thrombosis, sepsis, multiple types of organ failures and dysfunctions (hepatic dysfunction, respiratory failure, renal failure and right heart failure) and death as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.Section 6 entitled "patient care and management" (under "pump performance monitoring") outlines indications of pump thrombosis as well as how to respond to such events.Section 6 (under "anticoagulation") also outlines the suggested anticoagulation regimen and inr range that should be maintained for patients using the heartmate ii lvas.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSISST) 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: 11771226
• MDR Text Key: 248859771
• Report Number: 2916596-2021-02426
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: 106016
• Device Catalogue Number: 106016
• Device Lot Number: 6538461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 07/26/2021
• Supplement Dates FDA Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2018
• 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): Death; Life Threatening; Required Intervention