MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524US

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

Patient Problems Encephalopathy (1833); Headache (1880); Sepsis (2067); Lethargy (2560); Convulsion/Seizure (4406); Hemorrhagic Stroke (4417)

Event Date 02/07/2022

Event Type  Death  

Event Description

It was reported that the patient had multiple comorbid conditions including severe congestive heart failure and cardiogenic shock with history of left ventricular assist device implanted in 2021.The patient presented with lethargy, generalized weakness, headache, cough, and confusion to the emergency room.The patient was having seizure activity, twitching on the left side of the face, left arm was jerking, body was stiff, and had rapid eye movements.A computed tomography was performed and showed a 5 by 3 centimeter right hemorrhagic stroke.The patient had an acute large right parietal hemorrhagic stroke, acute metabolic encephalopathy, warfarin coagulopathy, severe sepsis, possible bilateral pneumonia.Doxycycline, warfarin, and complete comfort measures with no stroke order set, only ordered vitals, dilaudid drip, and other comfort medications.The vad was turned off and the patient passed away.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported events (stroke, sepsis, infection) and subsequent patient outcome as well as a direct correlation to heartmate 3 left ventricular assist system (lvas), serial number (b)(4), could not be conclusively determined through this evaluation.The device was not explanted, and product was not returned for evaluation.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specification.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) rev.C is currently available.¿introduction¿, lists stroke, bleeding, sepsis, infection, and death as adverse events that may be associated with the use of heartmate 3 lvas.¿patient care and management¿, provides information regarding anticoagulation, including recommended international normalized ratio (inr) values.Additionally, care instructions in reference to preventing infection are provided in various sections of this ifu.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported events (stroke, sepsis, infection) and subsequent patient outcome as well as a direct correlation to heartmate 3 left ventricular assist system (lvas), serial number (b)(4), could not be conclusively determined through this evaluation.The device was not explanted, and product was not returned for evaluation.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specification.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) rev.C is currently available.¿introduction¿, lists stroke, bleeding, sepsis, infection, and death as adverse events that may be associated with the use of heartmate 3 lvas.¿patient care and management¿, provides information regarding anticoagulation, including recommended international normalized ratio (inr) values.Additionally, care instructions in reference to preventing infection are provided in various sections of this ifu.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient had multiple comorbid conditions including severe congestive heart failure and cardiogenic shock with history of left ventricular assist device implanted in 2021.The patient presented with lethargy, generalized weakness, headache, cough, and confusion to the emergency room.The patient was having seizure activity, twitching on the left side of the face, left arm was jerking, body was stiff, and had rapid eye movements.A computed tomography was performed and showed a 5 by 3 centimeter right hemorrhagic stroke.The patient had an acute large right parietal hemorrhagic stroke, acute metabolic encephalopathy, warfarin coagulopathy, severe sepsis, possible bilateral pneumonia.Doxycycline, warfarin, and complete comfort measures with no stroke order set, only ordered vitals, dilaudid drip, and other comfort medications.The vad was turned off and the patient passed away.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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: 13608201
• MDR Text Key: 286224852
• Report Number: 2916596-2022-00881
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/14/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7762353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2020
• 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): Death
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 108 KG