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 Syncope (1610); Low Blood Pressure/ Hypotension (1914); Hematuria (2558)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

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 presented to the clinic on (b)(6) 2018 for rpm echocardiogram.The echocardiogram showed that lv's measured in the high 7's.The patient was admitted to the hospital on (b)(6) 2018, and was started on iv diuretics and diuresed 1 liter.The patient became hypotensive and was transferred to the intensive care unit.A swan-ganz catheter was placed and filling pressures were found to be normal.Iv diuretics were stopped when the patient had low flow alarms with each dose.Additionally, the patient had a syncopal episode and fell on their head.The patient had a headache and the head ct was unremarkable.The patient's international normalized ratio was found to be subtherapeutic, which required holding anti-coagulation for a few days, but was restarted prior to discharge.The patient was also experiencing hematuria at the time of hospitalization.

Manufacturer Narrative

Section d4: the heartmate 3 lvas was implanted during the momentum 3 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).Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the reported events could not conclusively be established through this evaluation.Additionally, the report of low flows could not be confirmed as no log files were provided for review.The patient remained ongoing on heartmate 3 lvas, serial number (b)(6) until (b)(6) 2020, when the patient was routinely transplanted.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The relevant sections of the device history records for the percutaneous lead were also reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 01mar2017.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of this document lists bleeding as an adverse event that may be associated with the use of the heartmate 3 lvas.Section 1 provides an explanation of all pump parameters, including flow.Section 4 provides information for the system monitor describing the pump flow display and the hazard alarms.This ifu states that the low flow hazard alarm will be triggered when pump flow is less than 2.5 liters per minute (lpm).The ifu explains that changes in patient conditions can result in low flow.Section 6 ¿patient care and management¿ (under "anticoagulation") outlines the recommended anticoagulation regimen (including international normalized ratio (inr) 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 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 is also currently available.Section 5 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.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: 10898076
• MDR Text Key: 218573068
• Report Number: 2916596-2020-05475
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Model Number: 106524
• Device Lot Number: 5881850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 37 YR
• Patient Weight: 69