MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS

Model Number 106524

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

Patient Problems Cardiac Arrest (1762); Death (1802); Edema (1820); Swelling (2091); Dizziness (2194); Weight Changes (2607); Swelling/ Edema (4577)

Event Date 10/07/2020

Event Type  Death  

Manufacturer Narrative

The heartmate 3 lvas was implanted during the (b)(6) clinical trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).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 contacted the clinic on (b)(6) 2020 reporting weight gain, swelling and shortness of breath and the patients diuretics were adjusted (changed from furosemide to torsemide.The patient went to clinic (b)(6) 2020 with complaints of dizziness - doppler 50 (flow 3.6, rpm 5000, pi 6.4, power 3.5).All diuretics held and blood pressure medication stopped.The patient had no low flow alarms at appointment.On (b)(6) 2020, the patient called back with low flow alarms; however, was asymptomatic (flow 1.8, rpm 5000, pi 11.4, power 3.5).Patient' healthcare team felt the low flows were associated with the patient's history of hypertension (especially since all bp (blood pressure) medications were previously held).It was reported that some medications were restarted.The patient called almost daily from (b)(6) 2020 to (b)(6) 2020 where on several occasions the patient's bp medications were slowly up-titrated.The frequency of low flow alarms was slowly decreasing as the patient¿s blood pressure was better managed with previous few days only having low flow alarms in the morning and late evening when it was believed medications were wearing off.On (b)(6) 2020, the patient's spouse called reporting the patient was unresponsive and having low flow alarms (flow 1.8).Emergency medical service (ems) was called and after roughly five minutes flows continued to drop to 0.9 lpm.Cardiopulmonary resuscitation (cpr) was not initiated by ems despite the center giving verbal orders.Upon arrival to the emergency room (er), cpr (cardiopulmonary resuscitation) was initiated and flows at that time were 1-1.5 lpm.The patient remained asystolic and cpr terminated.The patient reported to have expired on (b)(6) 2020 with the cause of expiration to be presumed cardiac arrest.The pump will not be returning for analysis.No further information was provided.

Manufacturer Narrative

Manufactures investigation conclusion: the reported low flow hazard alarms could not be confirmed as no log files were returned for evaluation.Heartmate 3 left ventricular assist system (lvas) was not explanted for investigation.The account attributed initial alarms due to hypertension; a correlation between the device and the reported hypertension, presumed cardiac arrest, and patient outcome could not conclusively be determined.A specific cause for reported hypertension and presumed cardiac arrest could not be conclusively determined.The account stated that the patient presumably died of cardiac arrest.A cause for the alarms the patient experienced on the date of death could not be conclusively determined.The account reported that the patient reported weight gain, pain, swelling, and shortness of breath.They received changes to diuretics.The patient came to the clinic several weeks later with complaints of dizziness and low blood pressure.Diuretics were held and blood pressure medications were stopped.The patient then began experiencing low flow alarms that the clinic felt were related to hypertension, and so some medications were restarted.The patient continued to experience alarms, but less frequently as medications were up titrated, only experiencing alarms when medications were wearing off in the morning and at night.On (b)(6) 2020, the patient was found unresponsive and having low flow alarms.Flow continued to decrease as emergency medical services arrived.Cardiopulmonary resuscitation (cpr) was initiated upon arrival to the emergency room.The patient remained a systolic and cpr was terminated.The patient expired.The patient¿s implantable cardioverter-defibrillator could not be interrogated for more information.The heartmate 3 lvas instructions for use (ifu) explains that the low flow hazard alarm will be triggered when pump flow is less than 2.5 lpm for 10 seconds or more, and notes that changes in patient conditions, including hypertension, can result in low flow.This document also lists hypertension and death as possible adverse events associated with the lvas.This ifu, as well as the heartmate 3 lvas patient handbook, describes all system alarms and the recommended actions associated with them.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11017264
• MDR Text Key: 221706635
• Report Number: 2916596-2020-05986
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Model Number: 106524
• Device Catalogue Number: 106524US
• Device Lot Number: 5787274
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Weight: 84