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

Model Number 106524US

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Myocardial Infarction (1969); Right Ventricular Dysfunction (2054); Thrombus (2101); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 04/15/2020

Event Type  Injury  

Manufacturer Narrative

The patient transplant is covered under mfr # 2916596-2020-05850.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient had a history of bacteremia of unclear origin.The patient's first positive blood cultures were drawn on (b)(6) 2020.It was additionally reported that the source of the infection was never fully identified.The patient had multiple indwelling lines at the time, so the infection could have been from a peripherally inserted central catheter (picc) or previous temporary right ventricular assist device (rvad).The patient's driveline never appeared infected, nor did it ever have any positive cultures.The patient also had a mobile echogenicity near the inflow cannula that was identified on echocardiogram (b)(6) 2020.It is unclear what the true source of the infection was.The patient initially complete 6 weeks of intravenous vancomycin and then transitioned to oral doxycycline for chronic suppression until their transplant.It was reported that the patient never had any clinical complications from the mobile echogenicity near the inflow cannula.When asked if the mobile echogenicity was considered to be thrombus, calcification, or bacterial vegetation, the vad coordinator responded by saying that it was considered thrombus because of the fact that it was small and disappeared in subsequent echocardiograms.The patient was placed on an rvad (abbott centrimag) at the time of implant as the patient was decannulated from extracorporeal membrane oxygenation (ecmo).At that time, the patient had a massive myocardial infarction (mi) which caused ventricular septal defect (vsd) and needed right ventricle (rv) support in additional to left ventricle (lv) support initially.The patient was decannulated from the rvad on (b)(6) 2020 and did well with his vad after discharge.The patient has since been transplanted.Of note, the patient underwent multiple transthoracic echocardiograms (tees) to track patient condition from (b)(6) 2020 to (b)(6) 2020.These tees noted moderate right ventricle (rv) enlargement and dysfunction, trace mitral regurgitation and mild tricuspid and aortic regurgitation.These tees are also how the clinicians visualized small thrombi in the inflow cannula and right coronary sinus, both of which dissipated.

Manufacturer Narrative

Section b3: event date corrected to when the patient was implanted.Events began starting on the date of implantation.Manufacturer's investigation conclusion: a specific cause for the reported bacteremia, mobile echogenicity, and myocardial infarction, as well as a direct correlation to heartmate 3 left ventricular assist system (lvas), serial number (b)(6), could not be conclusively determined through this evaluation.The patient remained ongoing on heartmate 3 lvas, serial number (b)(6), until ultimately undergoing a transplant on 13nov2020 (refer to manufacturer report number 2916596-2020-05850).No product is available for investigation.Heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.This ifu lists localized infection, driveline infection, and pump pocket or pseudo pocket infection as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system in section 1, ¿introduction¿.Care instructions regarding preventing infection are provided in section 6, ¿patient care and management¿.The heartmate 3 lvas patient handbook is also currently available.Care instructions for preventing infection are outlined in various sections of this document.The current heartmate 3 lvas ifu lists pump thrombosis as an adverse event that may be associated with the use of heartmate 3 left ventricular assist system in section 1, ¿introduction¿.This ifu also lists thromboembolism as a potential late postimplant complication that may be associated with the use of the heartmate 3 lvas in the section 6, ¿patient care and management¿.This section also contains information regarding the recommended anticoagulation therapy and inr range.Section 5, "surgical procedures" (under ¿preparing the ventricular apex site¿), instructs to inspect the ventricular chamber for mural thrombi and crossing trabeculae following removal of the core and to address one or both, as needed.Furthermore, section 5, under ¿implant procedures¿, warns to inspect the ventricle and remove any previously formed clots that may cause embolism or any trabeculae that may impede flow.The heartmate 3 lvas ifu lists myocardial infarction as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system in section 1, ¿introduction¿.Additionally, although the reported right heart dysfunction and subsequent rvad placement were due to a massive myocardial infarction and the account reported that the dysfunction was not device related, section 6 entitled ¿patient care and management¿ cautions the user that right heart failure can occur following implantation of the pump and warns that ¿right heart 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¿.This section also outlines the associated treatment options, including rvad placement.The relevant sections of the device history records for (b)(6) and the percutaneous lead were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 13apr2020.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
• MDR Report Key: 10992969
• MDR Text Key: 220962275
• Report Number: 2916596-2020-05910
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7430524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG ACUTE CIRCULATORY SUPPORT SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 82