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

Model Number 106524US

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Hemothorax (1896); Low Blood Pressure/ Hypotension (1914); Pain (1994); Skin Infection (4544); Drug Resistant Bacterial Infection (4553)

Event Date 10/20/2023

Event Type  Injury  

Manufacturer Narrative

Related manufacturer reference number: 2916596-2023-07729.(previous event where debridement for infection occurred).Related manufacturer reference number: 2916596-2023-07909 (previous event covering the onset of chronic driveline infection).No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Event Description

It was reported that the patient was seen in clinic after they heard a "pop" in their chest after lifting a couch.Upon arrival, their mean arterial pressures were in the 40s and low 50s mmhg.They had complaints of pain, and they were admitted to the hospital for concerns of sepsis.It was noted that the patient initially thought the swelling and pain at their old thoracotomy sit was from a retained stitch.They had leukocytosis and positive blood cultures with methicillin-sensitive staphylococcus and methicillin-resistant staphylococcus aureus; they were started on antibiotics.The computed topography (ct) scan revealed hemorrhaging blood in the chest that was coming out of their old left thoracotomy incision; the hemorrhage was thought to be encapsulated.The following morning, they were taken into the operating room (or) for chest exploration.The site was cleaned and dressed under sterile technique and bleeding was to be watched for from site.About 6 hours later, the patient sat up in bed with sudden extreme pain in their chest.The ventricular assist device (vad) had continuous low flow alarms with flow between 0.8-0.9 liters per minute.They were hemorrhaging out from thoracotomy site.They were taken emergently to the or.The patient received 60 units of blood products and the surgeon found a tear in the outflow graft.There was a concern that the bend relief was not engaged, and the proximal metal end was not engaged and rubbed on the outflow graft causing the tear.The tear was repaired, and the patient returned to the intensive care unit (icu) intubated with open chest and wound vacuum.Their chest was closed 6 days later.There was no more bleeding following surgery.They remained in icu but were stabilizing and improving.They were extubated on room air and given a peripherally inserted central catheter (picc) line for antibiotics.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events, including outflow graft damage resulting in a blood leak, low flow alarms, and the disconnection of the outflow graft bend relief, could not be confirmed through this evaluation as no photos or log files were submitted and the device remains in use.Additionally, a specific cause for these events and the reported sepsis could not be conclusively determined through this evaluation.It was reported that the patient was seen in clinic after they heard a "pop" in their chest after lifting a couch.The patient had complaints of pain and was admitted to the hospital with concerns for sepsis.The patient had leukocytosis and positive blood cultures.They were started on antibiotics.A computed topography (ct) scan revealed an acute blood collection in their chest that was thought to be encapsulated.Approximately 6 hours later the patient sat up in bed with sudden, extreme chest pain and was hemorrhaging out from their thoracotomy site with the ventricular assist device (vad) continuously alarming for low flow.The patient was brought to the operating room emergently and received a massive transfusion protocol.The surgeon found and repaired a tear in the outflow graft.No more bleeding was observed following the surgery.The patient remained in the intensive care unit and was improving with a peripherally inserted central catheter (picc) line for continued antibiotics.Although it was reported there was concern that the outflow graft bend relief was disengaged and rubbed on the outflow graft causing the tear, the account later communicated they were unable to determine what caused the tear in the outflow graft.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6) , and no further related events have been reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C is currently available.Section 1 "introduction" lists sepsis and bleeding as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Care instructions in regard to preventing infection are provided in various sections of this ifu, including a section entitled "controlling infection." section 1 also provides an explanation of all pump parameters (including flow).Section 4 "system monitor" provides information about the low flow hazard alarm condition and states that the low flow hazard alarm will be triggered when the estimated pump flow is less than 2.5 lpm.Changes in patient conditions can result in low flow.Section 5 of the ifu, "surgical procedures", provides information regarding how to prepare the sealed outflow graft for implant and includes steps for attaching the outflow graft to the pump.Section 5, under "de-airing the pump", explains that when de-airing is completed, slide the bend relief over the metal fitting of the sealed outflow graft toward the locking screw ring until it engages into place.This section warns that failure to connect the bend relief so that it is fully and evenly connected can allow kinking and abrasion of the graft, which may lead to serious adverse events such as low left ventricular assist device flow and/or bleeding.This section then instructs the user to visually inspect the bend relief to confirm that it is fully connected and seated to the sealed outflow graft.To confirm, try to unseat the connected bend relief from the metal fitting by gently pulling the bend relief back toward the anastomosis and then towards the pump.The bend relief should remain captured and move approximately 0.5 mm without disengaging from the graft.Section 5, under "securing the pump and connections", cautions that care should be taken to ensure that the sealed outflow graft bend relief remains connected during sternal closure.The ifu instructs that once the flow through the blood pump is satisfactory, ensure that the sealed outflow connections are dry and secure.Obtain hemostasis and close all wounds in the standard fashion.Section 6 ¿patient care and management¿ (under "anticoagulation") outlines the recommended anticoagulation regimen (including inr, international normalized ratio, range) for patients using the heartmate 3 lvas as well as the suggested anticoagulation modifications in the event that there is a risk of bleeding.Section 6 also contains a section on "blood leak diagnosis" and explains that a blood leak from any implanted component of the system can be identified through unexplained internal bleeding (beyond the perioperative period following implant), possibly with painful distension of the abdomen or tamponade.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.The heartmate 3 lvas patient handbook, rev.D, is also currently available.Section 5 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.This document instructs the user that in the event of a low flow hazard alarm, call your hospital contact immediately for diagnosis and instructions.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: 18103265
• MDR Text Key: 327749331
• Report Number: 2916596-2023-07676
• 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: Physician
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/04/2022
• Device Model Number: 106524US
• Device Lot Number: 8004579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native