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

Model Number 106524

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

Patient Problems Atrial Fibrillation (1729); Hypoxia (1918); Renal Failure (2041); Right Ventricular Dysfunction (2054)

Event Date 07/28/2018

Event Type  Injury  

Manufacturer Narrative

The heartmate 3 lvas was implanted during the (b)(6) trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing (b)(6).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 was experiencing poor right ventricle (rv) function.The patient was failing to thrive following vad implant.The site claimed that the primary issue appeared to be rv dysfunction causing an acute kidney injury, also with significant hypoxemia.The patient is poorly responsive to diuretic.Will add ino via nc today.The site continued milrinone, hold diuresis.Allow mean arterial pressure to run 85.Continue foley catheter.Inotropes were started on (b)(6) 2018 and discontinued on (b)(6) 2018.Ino was started on (b)(6) 2018 and weaned off on (b)(6) 2018.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the reported events could not be conclusively determined through this evaluation.The account communicated that on (b)(6) 2018, the patient developed atrial fibrillation (afib) with rapid ventricular response (rvr), the cause of which was reported as poor right ventricular function.The right ventricular dysfunction also caused hypoxia and acute kidney injury with creatinine levels rising above 2.0.The patient was treated with inotropes, nitric oxide, amiodarone, and lasix.According to the account, the event resolved on (b)(6) 2018 and the patient was stable and discharged on (b)(6) 2020.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No product available for investigation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on 21may2018 under order (b)(4).The current heartmate 3 lvas ifu lists right heart failure and renal dysfunction as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system in section 1, ¿introduction¿.Section 6 entitled ¿patient care and management¿ cautions the user that right heart failure can occur following implantation of the pump and outlines the associated treatment options, including rvad placement.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: 10656659
• MDR Text Key: 210648221
• Report Number: 2916596-2020-04869
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 106524
• Device Catalogue Number: 106524
• Device Lot Number: 6407126
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 80