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 Syncope (1610); Ventricular Tachycardia (2132)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: analysis of the submitted log files confirmed multiple pulsatility index (pi) events, which the center attributed to periods of non-sustained vt (ventricular tachycardia).The center also attributed the reported syncope to the vt.A direct correlation between the reported vt and heartmate 3 left ventricular assist system (hm3 lvas), serial number (b)(4) could not be conclusively established through this evaluation.The system controller event log files contain data from 09sep2020 at 22:32:33 through 18sep2020 at 07:07:22 and 21sep2020 at 15:08:02 through 23sep2020 at 02:00:34.No atypical alarms were captured for the duration of the files.179 total pulsatility index (pi) events were captured.The pump operated as intended at the set speed.Additional requests for additional information regarding the cardiac arrhythmia were sent to the center; however, no further details were provided.The patient remains ongoing on hm3 lvas, serial number (b)(4) and no additional complaints have been reported at this time.The hm3 lvas instructions for use (ifu) lists cardiac arrhythmia as an adverse event that may be associated with the use of the hm3 lvas.The ifu explains that pi events are assumed by the system during cases when there are sudden and substantial changes in the pulsatility index.These events are also referred to as pi events, and may be initiated for reasons other than true pi events.Some reasons include sudden changes in a patient¿s volume status, arrhythmias, sudden changes in power, and sudden changes in pump speed.If the system detects a pi event, the pump speed automatically drops to the low speed limit and slowly ramps back up at a rate of 100 rpm per second to the fixed speed setpoint.The relevant sections of the device history records for (b)(4) 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 13aug2018.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient presented to the emergency room with syncope.The patient's log file was reviewed by technical services and they noted low flow advisories associated with high pi readings.The patient received a shock from their implantable cardioverter-defibrillator (icd) and upon interrogation of the icd, the pi events and syncopal events were associated with periods of non-sustained ventricular tachycardia.The patient had an endocardial catheter ablation and the patient has not had another episode and excessive pi events resolved.

• 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
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 11068627
• MDR Text Key: 223606944
• Report Number: 2916596-2020-06139
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2021
• Device Model Number: 106524
• Device Lot Number: 6572501
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 97