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

Model Number 106524US

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Valve Stenosis (2024); Liver Failure (4492)

Event Date 03/24/2022

Event Type  Injury  

Event Description

It was reported that the patient had a heartmate 3 pump (hm3) explanation and an extracorporeal membrane oxygenation (ecmo) circuit attachment on (b)(6) 2022.The patient was diagnosed with left pulmonary artery stenosis that prevented the left lung from developing.Bronchoscopy showed compression of the left bronchus.Their transpulmonary gradient (tpg) was extremely high when ecmo circuit clamped off with the patient sedated and paralyzed.The heart failure team determined based on the pressures with patient in this state, optimization of their tpg would be especially important since the ventricle recovered a degree of contraction which obstructs hm3 inflow cannula.Meanwhile, the patient¿s total bilirubin continues to climb, which concerned providers for worsening liver congestion and liver failure.With their elevated tpg and challenges unloading the ventricle based on patient anatomy, the providers determine to covert the patient to a single mcs circuit with inline oxygenator.The surgeon decided to immediately bring the patient back to or to explant hm3 and place centrimag with berlin heart cannulas.The patient was brought to operating room and prepped in sterile fashion.A sternal incision was made and hm3 system was carefully dissected.A new left atrial line was placed.With ecmo flow at 2.5lpm, hm3 at 5400rpm, 4.8lpm, 3.9w, and pi 3.6; hr 83, bp 91/70/82, pfontan 19, patria 9.With chest opened, decided to trial ecmo and hm3 adjustment with the guidance of a transesophageal echocardiogram (tee) and pressure readings.Ecmo flow increased to 3.5lpm, hm3 increased to 6300rpm, 5.3lpm, but tpg remained between 10 and 11.After discussion with surgeon and heart failure cardiologists, decision was made to proceed with hm3 explant and centrimag support.Patient was carefully switched via existing ecmo cannulas to cpb support once rotoflow ecmo circuit and hm3 were simultaneously ceased.Cardioplegia was given and heart was stopped.Hm3 was carefully removed from mini apical cuff prior to excision of the mini cuff from the heart.The driveline was cut on the velour and surgeon placed a heavy silk tie over a sterile glove tip that was placed over the exposed wires of the tunneled portion.The doctor created a gortex patch with interrupted prolene sutures, which were brought from endocardium through the myocardium to a second 30mm circular patch of a layer of felt with 0.6mm gortex circle on top.The prolene sutures were tied off and another running 5-0 prolene suture around the patch.An evarrest patch was also placed to minimize bleeding at the patched site.The out flow graft (ofg) was cut above the bend relief to use with a berlin heart cannula for the centrimag circuit.The existing hm3 tunneled driveline was removed from the external ¿dirty¿ side and tied off glove remained intact covering the cut driveline.The common atria was then surgically opened.Fenestrations were created with an aortic punch between the common atria and fontan graft.The appropriately sized berlin heart cannulas were selected and tunneled exiting the patient¿s upper abdomen.The doctor placed the venous cannula in the opened atria, which was sutured closed via the cannula.The doctor then placed the arterial cannula in the existing hm3 ofg and secured it with heavy silk ties.Connection of berlin heart cannulas were then made to primed centrimag, which had a quadrox oxygenator spliced on the centrimag outlet tubing.The patient was carefully transitioned from cardiopulmonary bypass (cpb) to centrimag/quadrox support.Patient hemodynamics were significantly improved with hr 78, map 76, pfontan 9, patria 5, and flow of 4.3lpm at 3200rpm on the centrimag.Tpg was significantly improved to 4 with this circuit.The patient¿s chest was closed and the patient was transferred to the cardiovascular intensive care unit (cvicu) in stable condition.The surgeon requested the explanted hm3 be returned.Additional information revealed pump malposition which was confirmed via echocardiogram.The patient had complex single ventricle physiology with their right ventricle (rv) acting as their system ventricle.Plans to continue the patient's lung rehabilitation were made with hopes of coming off ecmo and being listed for transplant.The patient's heartmate3 will remain with the hospital and won't be returned to abbott for repair.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported pump malposition and left pulmonary artery stenosis could not conclusively be established through this investigation as no images were submitted and the device was not returned for evaluation.The patient remains ongoing on a centrimag and quadrox oxygenator circuit.No product was returned for investigation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on 14jun2021.The most recent revision of the heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is 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.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: 14053026
• MDR Text Key: 288885303
• Report Number: 2916596-2022-01981
• 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
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7988064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• 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): Life Threatening; Hospitalization
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 45 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White