MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP; VENTRICULAR (ASSIST) BYPASS

Model Number 104911JPN

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

Patient Problems Liver Damage/Dysfunction (1954); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) ii left ventricular assist system (lvas), serial number (b)(4), and the reported events could not be conclusively determined through this evaluation.The patient remains ongoing on heartmate ii lvas, serial number (b)(4).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 (b)(6) 2017.The heartmate ii lvas ifu and the heartmate ii patient handbook document are currently available.The ifu lists right heart failure and hepatic dysfunction as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.The ifu states that 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.This document also discusses the potential development of right heart failure during use of the heartmate ii lvas and outlines the associated treatment options.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient was admitted for hepatic dysfunction.The possibility was low but undeniable because the hepatic dysfunction was considered to be due to the patient¿s declining right ventricular function.Cardia catherization was performed.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP
• 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: 15113263
• MDR Text Key: 296689146
• Report Number: 2916596-2022-12462
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: 104911JPN
• Device Lot Number: 6168543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2017
• 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): Required Intervention; Hospitalization
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 47 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian