MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

Model Number 106524US

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

Patient Problems Death (1802); Unspecified Infection (1930); Right Ventricular Dysfunction (2054)

Event Date 08/09/2019

Event Type  Death  

Manufacturer Narrative

The patient's previous admission and onset of the mentioned ongoing bacteremia was reported under mfr # 2916596-2019-04732.Manufacturer¿s investigation conclusion: a specific cause for the patient's infection could not conclusively be determined through this evaluation.Additionally, a direct correlation between the reported event and heartmate 3 lvas, serial number (b)(4) could not conclusively be determined through this evaluation.It was the pump would not be returned for evaluation.The hm3 lvas ifu lists infection, right heart failure, renal dysfunction, and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.This ifu, as well as the hm3 lvas patient handbook, also provide information regarding how to prevent infection.It also states ¿right heart failure can occur following implantation of the pump.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.

Event Description

It was reported that the patient was readmitted with volume overload and renal failure requiring dialysis.The course was complicated by delirium.The patient also experienced right ventricular dysfunction requiring inotropes and ongoing bacteremia.The patient's family chose to place the patient on hospice.The patient expired on (b)(6) 2019.No further information was provided.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 9219114
• MDR Text Key: 163190074
• Report Number: 2916596-2019-04804
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/19/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6776202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2018
• 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
• Patient Age: 59 YR
• Patient Weight: 96