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

Model Number 10010511

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

Patient Problems Heart Failure/Congestive Heart Failure (4446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/01/2022

Event Type  Death  

Manufacturer Narrative

(b)(4).Manufacturer's investigation conclusion: a direct relationship between the device and the reported multi organ failure, including right heart failure, and patient outcome could not be conclusively determined through this evaluation.(b)(4) was not explanted and was not returned for evaluation.Review of the device history records showed no deviations from manufacturing or qa (quality assurance) specifications.The heartmate 3 lvas if is currently available.Multiple organ failures, including right heart failure, and death are listed as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.The system monitor section describes the pump flow display (4-12 through 4-14) and the hazard alarms (4-18 and 4-26).This ifu states that the low flow hazard alarm will be triggered when pump flow is less than 2.5 liters per minute (lpm) and explains that changes in patient conditions can result in low flow, such as hypertension.The alarms and troubleshooting section describes the actions to take in the event of a low flow alarm (7-7 and 7-11).No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient passed away.The cause of death was determined to be progressive right ventricular failure and multisystem organ failure.The patient was in comfort care as death was imminent.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSIST) 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: 15005158
• MDR Text Key: 295823077
• Report Number: 2916596-2022-12191
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/30/2022
• Device Model Number: 10010511
• Device Lot Number: 7244653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2019
• 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: 13 YR
• Patient Sex: Female
• Patient Weight: 27 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native, White