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

Model Number 106524

Device Problems Break (1069); Mechanical Problem (1384); High Readings (2459)

Patient Problem Ventricular Tachycardia (2132)

Event Date 07/02/2019

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

Source review revealed that patient had ventricular tachycardia on (b)(6) 2019 which resulted in antitachycardia pacing (atp).The document mentioned that the patient had a st.Jude device and there was rescue tape on driveline.It was also reported that damage to external driveline was observed with replacement recommended; however, ventricular assist device (vad) interrogation on (b)(6) 2019 notes stated that there was normal lvad function and settings appeared to be appropriate.The driveline and all components of the vad appear intact and to be functioning normally.There were multiple pi events.

Manufacturer Narrative

Section g3 and h4: correction.Manufacturer's investigation conclusion: a specific cause for the reported cardiac arrhythmia and frequent pi events, as well as a direct correlation to heartmate 3 lvas, serial number (b)(6), and to each other, could not conclusively be determined through this evaluation.The reported frequent pi events could not be confirmed as no log files were submitted for review.The account communicated that the patient had ventricular tachycardia with a heartrate of 200 bpm on (b)(6) 2019.Log file analysis reportedly showed multiple pi events but device interrogation showed normal lvad function and parameters appeared appropriate.There were no alarms associated with this event.Additional information was requested, but not provided.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No product is available for investigation.It was noted that the patient continued to have issues with cardiac arrhythmia and frequent pi events on (b)(6) 2020 (referenced in manufacturer report number #2916596-2020-04419).The heartmate 3 lvas ifu lists cardiac arrhythmia as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.The heartmate 3 lvas ifu also provides an explanation of each of the pump parameters (including pulsatility index), addresses pi events as well as potential causes, and explains how to determine the optimal fixed speed and low speed limit for the patient.This document additionally states that there are no audible alarms with a pi event.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 (b)(6) 2017.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: 10567352
• MDR Text Key: 207944996
• Report Number: 2916596-2020-04540
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• 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 Catalogue Number: 106524US
• Device Lot Number: 5869731
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 103