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

Model Number 106524US

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemolysis (1886); Renal Failure (2041); Septic Shock (2068); Cardiogenic Shock (2262); Anxiety (2328); Lactate Dehydrogenase Increased (4567); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/02/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturer report number: 2916596-2022-11830.It was reported that the patient had a lactate dehydrogenase (ldh) spike overnight on (b)(6) 2022.There were no left ventricular assist device (lvad) alarms.A review of the log files revealed no unusual alarms recorded from (b)(6) 2022- (b)(6) 2022.Additional information revealed that the patient was admitted to the intensive care unit (icu) post-operatively for cardiogenic shock.The patient's hemodynamic status was closely monitored with invasive techniques.They remained on epinephrine(auvi-q) and milrinone (primacor) in the post-op period.The patient was noted as having leukocytosis.Additionally, on (b)(6) 2022, the patient had decreased urinary output and elevated venous pressure.The patient had elevated creatinine levels (2.30 mg/dl).They were started on continuous veno-venous hemofiltration for acute renal failure.On (b)(6) 2022 the patient had signs of restlessness, anxiety, and delirium.Additional information revealed that on (b)(6) 2022 the patient was noted to have acute hypoxic respiratory failure.The patient was on a high flow nasal cannula and was transistioned to a bilevel positive airway pressure (bipap) machine for additional support.A chest x-ray found concerns for pneumonia.Broad spectrum antibiotics were started to treat the presumed pneumonia.Blood cultures were taken and found to be negative for infection.The patient was presumed to have septic shock.On (b)(6) 2022, the patient was taken to the operating room (or) for right ventricular assist device (rvad) implantation due to worsening right ventricular dysfunction as seen on an echocardiogram.Approximately two hours post operation, rvad flow began to drop to 2.6l with associated low flow events on the patient lvad.A bedside echocardiogram showed a dilated rv and a very small left ventricle (lv) cavity.Pump speeds were adjusted but the patient still had low flow events on both their lvad and rvad.The patient was given 3 units of packed red blood cells (prbc's) and 1l of albumin without improvement.A transesophageal echocardiogram was performed to evaluate the rvad's pump position, found a large clot compressing the right atrium.In total the patient received 5 units of prbc's, 4 units of fresh frozen plasma(ffp), 1 unit of platelets, and 1l of iv fluids.

Manufacturer Narrative

Section a4: patient privacy laws prohibit the release of private patient information and patient date of birth should have been removed from the previous report.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Section h6: health effect - clinical code: multiple organ dysfunction syndrome.Manufacturer's investigation conclusion.A specific cause for the reported multiorgan failure, infection, elevated lactate dehydrogenase (ldh), and patient conditions as well as a direct correlation with the device could not be determined through this evaluation.The submitted log files captured the pump functioning as intended.No atypical events were captured.It was reported that the patient¿s post-op course was complicated by right ventricular (rv) failure, renal failure, and respiratory failure.The patient was implanted with a centrimag blood pump and treated with inotropes due to their worsening rv failure.Other treatments included veno-venous hemofiltration for acute kidney failure, antibiotics for pneumonia, intubation for respiratory failure, and blood/plasma/platelet transfusions for anemia.The patient also experienced ileus which caused elevations of the patient¿s ldh.The patient remains in the intensive care unit and will continue to be monitored.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and centrimag blood pump.No product is available for investigation.The heartmate 3 lvas ifu, rev.C, lists various forms of organ failure (right heart, renal, and respiratory), infection, and hemolysis as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Care instructions in reference to preventing infection are provided throughout this ifu, including sections titled "caring for the driveline exit site" and "controlling infection." the relevant sections of the device history records for the (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on 24may2022.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.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: 14776258
• MDR Text Key: 294661186
• Report Number: 2916596-2022-11596
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8460467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American