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

Model Number 106524US

Device Problems Insufficient Information (3190); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2022

Event Type  malfunction  

Event Description

Evaluation of the log files confirmed transient increases in rotor noise associated with rotor noise fault flags.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the log files extracted (b)(4) confirmed multiple lvad internal fault flags associated with transient increases in rotor noise.A specific cause for these events could not be conclusively determined through this evaluation.The remaining device evaluation did not reveal any device-related issues.(b)(4) was returned assembled with the pump cable severed approximately 7¿ from the pump header, consistent with the explant procedure.The distal portion of the pump cable and the modular cable were not returned.The outflow graft was returned detached from the pump cover outlet port with the bend relief engaged the graft attachment.The outflow graft clip was returned detached from the sealed outflow graft hardware.The apical cuff was returned secured with the cuff lock fully engaged.Upon disassembly of the returned pump, examination of the blood-contacting surfaces revealed no adhered depositions or thrombus formations.Visual inspection of the pump rotor and rotor well did not reveal any obvious surface scratches or defects.The extracted left ventricular assist device (lvad) event log file contained relevant data from 15dec2021 through 16jan2022, per the timestamps.Multiple rot_noise fault flags were captured on 18dec2021.These flags were associated with four transient increases in rotor noise.A specific cause for the observed increases in rotor noise could not be conclusively determined through this evaluation.(b)(4) was cleaned, rebuilt, and functionally tested on a mock circulatory loop.The device operated as intended and in accordance with manufacturing specifications.Although no device related issues were reported by the account, the heartmate 3 instructions for use (ifu) lists adverse events that may be associated with the use of the heartmate 3 lvas.Additionally, the ifu and the heartmate 3 patient handbook outline all system alarms, including the lvad fault, and the recommended actions associated with them.The patient handbook also warns the patient to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.The relevant sections of the device history records for (b)(4) 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 patient handbook are currently available.Although no device related issues were reported by the account, the ifu, ¿introduction¿, lists adverse events that may be associated with the use of the heartmate 3 lvas.The ifu, ¿alarms and troubleshooting¿, outlines all system alarms, including the lvad fault, and the recommended actions associated with them.The patient handbook, ¿alarms and troubleshooting¿, outlines all system alarms, including the lvad fault, and the recommended actions associated with them.This handbook also warns the patient to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.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 (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: 14885673
• MDR Text Key: 303228081
• Report Number: 2916596-2022-12047
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/16/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7721189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2020
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 76 KG