MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 106015

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

Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Tachycardia (2095); Coma (2417); Respiratory Tract Infection (2420); Hemorrhagic Stroke (4417); Ischemia Stroke (4418)

Event Date 11/05/2021

Event Type  Death  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is completed.

Event Description

It was reported that on (b)(6) 2021 the patient was status/post a neurological event determined by log files and further studies (initially thought to be a cardiac arrest).The patient was unresponsive, had ventricular tachycardia (vt) and was cardioverted.The patient's labs were normal.Computed tomography angiography (cta) of the head revealed a non-traumatic subarachnoid hemorrhage.Log file analysis captured 3 low flow events on (b)(4) 2021 as well as multiple no external power events on (b)(4) 2021 and (b)(4) 2021.The no external powers were a result of the patient being confused after having a 2/2 embolic stroke where he had simultaneously disconnected himself from both controller leads.The low flows were caused by vt and resolved when patient was cardioverted.The patient's neurological state was irreversible from their comatose state.The patient passed away from an embolic stroke that transformed into a hemorrhagic stroke.The stroke was a result of the patient's covid infection with hypercoagulability state.The vad (ventricular assist device) was turned off on (b)(6) 2021.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate ii left ventricular assist system (lvas), serial number (b)(6), and the reported embolic stroke, hemorrhagic stroke, ventricular tachycardia, and patient outcome could not conclusively be established through this evaluation.Heartmate ii lvas, serial (b)(6), was not explanted.The submitted log file contained data from 16:08:55 on (b)(6) 2021 to 00:07:24 on (b)(6) 2021.Three transient low flow events were captured at 23:24:53, 23:25:46, and 23:26:25 on (b)(6) 2021 when calculated flow decreased to below the low flow threshold.The account attributed these events to ventricular tachycardia.Additionally, no external power events that the account attributed to the patient simultaneously unplugging both power cables were recorded in the log file.The device appeared to be operating as intended at the set speed.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of this ifu lists stroke, bleeding, cardiac arrhythmia, and death as adverse events that may be associated with the use of the heartmate ii lvas.Section 6 outlines the recommended anticoagulation therapy and international normalized ratio (inr) range.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• 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: 12934208
• MDR Text Key: 281748920
• Report Number: 2916596-2021-06748
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2016
• 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): Life Threatening; Death; Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 76 KG