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

Model Number 106524INT

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

Patient Problems Hemorrhage/Bleeding (1888); Pleural Effusion (2010); Urinary Tract Infection (2120); Vomiting (2144); Heart Failure/Congestive Heart Failure (4446); Renal Impairment (4499)

Event Date 01/14/2022

Event Type  Injury  

Event Description

It was reported that dialysis needed to be started due to acute renal dysfunction after the implant procedure.The patient vomited, once with a small amount of blood.The patient had right heart failure and had inotropic therapy more than seven days post implant.The patient had pleural effusion in the left pleural cavity.A pleural puncture was performed.

Manufacturer Narrative

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

Event Description

The patient also received parenteral antibiotics for urinary tract infection and remdesivir for covid-19 infection.The right heart failure existed prior to left ventricular assist device (lvad) implant, however, the renal function did not exist prior to lvad implant.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported events (right heart failure, bleeding, renal dysfunction, infection, patient condition) as well as a direct correlation to heartmate 3 left ventricular assist system (lvas), serial number (b)(6), could not be conclusively be determined through this evaluation.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6), with no further issues reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specification.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) and the heartmate 3 lvas patient handbook are currently available.Section 1 of the ifu, ¿introduction¿, lists right heart failure, bleeding, and renal dysfunction as potential adverse events that may be associated with the use of the heartmate 3 lvas.Section 6 of the ifu, ¿patient care and management¿, discusses the potential development of right heart failure following implant and outlines the associated treatment options.This section also provides information regarding the recommended anticoagulation regimen, including international normalized ratio (inr) values, as well as suggested anticoagulation modifications in the event that there is a risk of bleeding.Although no device-related infections were reported for this event, the ifu lists infection as an adverse event that may be associated with the use of heartmate 3 lvas.Both the ifu and patient handbook provide care instructions in regard to preventing infection.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

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 (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: 13515173
• MDR Text Key: 285855025
• Report Number: 2916596-2022-00655
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2023
• Device Model Number: 106524INT
• Device Lot Number: 8204761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 92 KG