MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 106015

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

Patient Problems Syncope (1610); Death (1802); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Sepsis (2067)

Event Date 10/13/2020

Event Type  Death  

Manufacturer Narrative

Chronic driveline infection addressed in mfr report number 2916596-2014-02302.Driveline infection in (b)(6) 2020 addressed under mfr report number 2916596-2020-06570.Drainage at driveline site in (b)(6) 2020 addressed under mfr report number 2916596-2020-06577.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 expired on (b)(6) 2020 due to sepsis associated with heartmate ii driveline infection.The patient had been dnr (do-not-resuscitate) for a while due to known driveline infection.The previous plan was to suppress the driveline infection with iv (intravenous) antibiotics, as the patient was not an appropriate candidate for more extreme interventions.The patient was transferred from outlying hospital due to sepsis, hyperkalemia, lactic acidosis, hypotension and low flows on the lvad (left ventricular assist device).Approximately four days prior the patient had a syncopal episode where patient passed out for approximately 30 seconds and was observed to turn blue and then came to.Since that time, the patient had not been feeling well and had been fatigued, without much energy to do very much.The patient had lvad since 2012 with her second replacement in 2014.Throughout the course with lvad, patient struggled with chronic driveline infection, with most recent culture in (b)(6) 2020 growing out pseudomonas aeruginosa.The patient was seen in september 2020 at the outpatient clinic where patient continued to have dizzy spells and struggled with increased drainage at driveline exit site.On (b)(6) 2020, upon examination patient's upper and lower extremities were cold/mottled, and patient was minimally responsive.Patient did respond initially to voice, and then as time went on, patient was not able to respond to verbal commands, or touch.Lvad flows, were exhibiting dashing signals, without readable flow, due to hypovolemia, with a doppler map in the low 50s.Low-dose dobutamine was started, as well as 5% albumin given to the patient.Speed was also adjusted on lvad from 9800 rpms to 9600 rpms, to allow for more filling pressures in lv (left ventricle).Patient did have an occasional reading in the low 2 l/min, but nothing sustainable.Heart rate was bradycardic, with heart rates in the low 20s, on up to high 60s.At approximately 1615 patient was found to be nonresponsive, with no flows on lvad, and unable to auscultate breath sounds, or heart rate.Additional assessment by a second nurse, without any pupillary response or response to pain.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the reported events: (syncopal event, patient condition, hypovolemia, bradycardia, driveline infection, sepsis, patient outcome) and heartmate ii left ventricular assist system (hmii lvas), serial number (b)(6) could not be conclusively established through this evaluation.A specific cause for the reported events could not be conclusively determined, through this evaluation.The reported low flow alarms could not be confirmed, through this evaluation as, no log files were submitted for review.The center attributed the low flows to hypovolemia.Hmii lvas, serial number (b)(6) was not explanted for evaluation.The hmii lvas instructions for use (ifu) lists driveline infection, sepsis, and cardiac arrhythmia as adverse events that may be associated with the use of the hmii lvas.Hypovolemia is listed as a potential late postimplant complication.The ifu explains, that changes in patient conditions can result in low flow.The ifu explains, that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.And that physiological factors that affect the filling of the pump, such as hypovolemia or postural hypotension, result in reduced pump flows as long as the condition persists.This document contains information about the system's alarms (including low flow hazard alarms).Care instructions for preventing infection are outlined in various sections of the ifu, as well as the hmii lvas patient handbook.The relevant sections of the device history records for (b)(6) were reviewed.And showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 17nov2014.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 II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11127173
• MDR Text Key: 225396979
• Report Number: 2916596-2020-06434
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 72 YR
• Patient Weight: 64