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

Model Number 106524US

Device Problem Failure to Align (2522)

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

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient's frequent pulsatility index (pi) events all correlate to suction events.Additional information revealed that the cause of the suction event was a inflow cannula malfunction.

Manufacturer Narrative

Manufacturer's investigation conclusion a direct correlation between the device and the reported inflow conduit misalignment could not conclusively be established through this investigation.The submitted log files captured transient pi throughout the log file, resulting in momentary decreases in speed per design.No atypical events were captured.The pump appeared to function as intended.The patient remained ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6), until they were transplanted on 21jul2022 (mfr# 2916596-2022-12853).No product is available for investigation.The heartmate 3 instructions for use (ifu) explains how to insert the pump in the ventricle and instructs the user to take care to avoid orienting the inlet towards the interventricular septum.Pump function will be compromised in the presence of inlet obstruction.This document also outlines the steps to reorient the pump.The most recent revision of the heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C, section 5 entitled ¿surgical procedures¿, explains how to insert the pump in the ventricle and instructs the user to take care to avoid orienting the inlet towards the interventricular septum.Pump function will be compromised in the presence of inlet obstruction.This section also outlines the steps to reorient the pump.The relevant sections of the device history records for mlp-026878 were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on 02jun2021.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: 14831549
• MDR Text Key: 296859190
• Report Number: 2916596-2022-11595
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/12/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7986242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 08/30/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 162 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White