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

Model Number 106524US

Device Problems Failure to Align (2522); Infusion or Flow Problem (2964)

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

Event Date 07/05/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient presented with low flow alarms.Scans showed a possible extrinsic outflow graft obstruction.No power spikes or elevated hemolysis markers were observed.Additional information was received that the patient restarted anticoagulants on (b)(6) 2022 after being completely off all anticoagulants since (b)(6) 2022 due to intraparenchymal hemorrhage.It was noted that flows were much lower than normal when the ct revealed the outflow graft obstruction.The outflow graft was stented and flows returned to baseline.Pump speed was lowered by 500 revolutions per minute (rpm) due to small left ventricle (lv) and malposition of inflow cannula.The patient was discharged to rehab.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of extrinsic outflow graft obstruction could not be confirmed through the evaluation of the submitted images and no product was returned for evaluation.Review of the log files provided by the account confirmed low flow events; however, a specific cause for these events could not be determined through this evaluation.Additionally, the reported inflow cannula misalignment could not be confirmed through the evaluation of the submitted images.The controller event log file contained data from (b)(6) 2022.No notable events or alarms were captured, and the pump appeared to function as intended at the set speed.The account provided three images for evaluation.Two of the images showed portions of the outflow cannula that were covered by the bend relief, however, the shape of the graft under the bend relief cannot be determined.The third image showed the stent that was surgically placed in the outflow graft.The patient remains ongoing on heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), and no further events have been reported at this time.The heartmate 3 lvas ifu, rev.C, and the heartmate 3 patient handbook, rev.D, are currently available.Section 1 of the ifu, "introduction", lists potential adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.This section also addresses all pump parameters.Section 4 of the ifu, ¿system monitor¿, describes the pump flow display and the hazard alarms.Per design, when the estimated flow value is calculated at less than 2.5 lpm, a low flow status is posted to the log file.If the flow remains below 2.5 lpm for 10 seconds, a low flow hazard alarm is triggered.Section 4 also explains that changes in patient condition can result in low flow.Section 5 of the ifu, ¿surgical procedures¿, provides instructions on how to insert the pump in the ventricle and instructs the user to take care to avoid orienting the inlet towards the interventricular septum as pump function will be compromised in the presence of inlet obstruction.The steps to adjust the orientation of the pump are also outlined in this section.Section 5 of the patient handbook and section 7 of the ifu, ¿alarms and troubleshooting¿, provides information on all system alarm conditions as well as the appropriate actions associated with each condition.A section on ¿handling emergencies¿ is also provided in this document.Section 5 of the ifu, "surgical procedures", contains information on "preparing the sealed outflow graft" and explains that prior to implantation, the bend relief should be disengaged from the graft for the de-airing procedure.Section 5 also contains a sub-section on "attaching the sealed outflow graft to the aorta", which instructs the user to stretch the graft completely and then measure and cut the sealed outflow graft to the appropriate length.Section 5 of the ifu, under "attaching the sealed outflow graft to the pump", instructs the user to verify that the outflow graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.Section 5 of the ifu, under "de-airing the pump", cautions the user: "do not rotate/twist the sealed graft.Check the alignment of the black line on the graft to verify that the sealed graft is not twisted or kinked." this section also explains how to attach the bend relief once the vent needle has been removed from the sealed outflow graft and leaks have been ruled out.Section 8 of the patient handbook, ¿handling emergencies¿, also provides examples of emergencies and the proper actions to take in the event an emergency occurs.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 17jan2019.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 (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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 15085050
• MDR Text Key: 296395996
• Report Number: 2916596-2022-12221
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/09/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6806448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FA-Q124-HF-1
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 68 KG