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

Model Number 106524US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Arrhythmia (1721); Purulent Discharge (1812); Erythema (1840); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Liver Damage/Dysfunction (1954); Pain (1994); Pleural Effusion (2010); Chills (2191); Presyncope (4410); Hallucination (4428); Heart Failure/Congestive Heart Failure (4446); Drug Resistant Bacterial Infection (4553)

Event Date 01/11/2022

Event Type  Injury  

Manufacturer Narrative

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 experienced post-operative pain on (b)(6) 2022 and required dilaudid and tylenol.The patient also developed both compensated metabolic acidosis and compensated lactic acidosis on (b)(6) 2022.The patient also developed a small bilateral pleural effusion.The patient reported on (b)(6) 2022 that since their surgery, their bilateral upper extremity baseline tremors had gotten worse.On (b)(6)2022, the patient had acute right ventricular failure with a increase in their central venous pressure (cvp).Vasodilators were administered.The patient experienced delirium with hallucinations on (b)(6) 2022.On (b)(6) 2022, the patient experienced transaminitis with levels 3 times greater than baseline that persisted past 14 days post-implant; these levels were downtrending.Rosuvastatin was withheld.On (b)(6) 2022, the patient developed scrotal and bilateral lower extremity edema.On (b)(6) 2022, the patient experienced driveline erythema with a thick, clear and yellow drainage.The patient experienced dizziness and rigors and chills; cultures were taken that confirmed the patient had a superficial dermacoccus nishinomiyaensis driveline infection.The patient was given intravenous vancomycin.The patient experienced bilateral foot pain on (b)(6) 2022.On (b)(6) 2022, the patient had worsening wide complex tachycardia that required multiple attempts to chemically and electrically cardiovert.The patient also had worsening baseline anemia on (b)(6) 2022 with low hemoglobin and hematocrit levels that required a blood transfusion.A routine rectal swab taken on (b)(6) 2022 revealed vancomycin resistant enterococci.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system, serial number (b)(6), and the reported events cannot be conclusively determined through this investigation.The report of low flow alarms could not be conclusively determined through this investigation as no log files from the time of the reported event were submitted by the account for evaluation.The patient remains ongoing on heartmate 3 left ventricular assist system, serial number (b)(6).Additional information regarding the events was requested from the account; however, nothing further has been communicated at this time.The relevant sections of the device history records were reviewed and showed no deviation from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system instructions for use (rev.C) contains the following information: section 1 lists cardiac arrhythmia, renal dysfunction, other neurological event (not stroke-related), right heart failure, infection, bleeding, and hypertension as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.Speed, power, flow, and pulsatility are also outlined in this section.Section 4 describes the pump flow display (4-13 through 4-15) and the hazard alarms (4-19 and 4-32).This section also states that the low flow hazard alarm will be triggered when pump flow is less than 2.5 liters per minute (lpm) and explains that changes in patient conditions can result in low flow.Section 6 lists neurological dysfunction, cardiac arrhythmia, and infection as potential late post-implant complications that may be associated with the use of heartmate 3 left ventricular assist system.This section states: "right heart failure can occur following implantation of the pump.Right ventricular dysfunction, especially when combined with elevated pulmonary vascular resistance, may limit the effectiveness of the left ventricular assist system due to reduced filling of the pump." information regarding anticoagulation therapy and international normalized ratio range can be found in this section.Section 7 describes the actions to take in the event of a low flow alarm (7-7 and 7-11).Care instructions regarding preventing infection are provided in various sections of this document.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

The patient had a related infection as reported under mfr #: 2916596-2022-15003.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was additionally reported on (b)(6) 2023 that the patient's post-operative pain resolved on (b)(6) 2022.Their right heart failure symptoms resolved on (b)(6) 2022.Their driveline infection resolved on (b)(6) 2022.Their anemia symptoms resolved on (b)(6) 2022.Their arrhythmia resolved on (b)(6) 2022.Their hepatic dysfunction resolved on (b)(6) 2022.Their vancomycin-resistant enterococci infection was considered resolved on (b)(6) 2022.

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 (ASSISST) 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: 13579221
• MDR Text Key: 287284855
• Report Number: 2916596-2022-00644
• 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,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/16/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8108339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 04/21/2022; 07/24/2023; 07/24/2023
• Supplement Dates FDA Received: 05/06/2022; 07/24/2023; 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White