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

Model Number 106524US

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

Patient Problems Respiratory Failure (2484); Convulsion/Seizure (4406)

Event Date 07/02/2022

Event Type  Death  

Event Description

It was reported that the patient passed away on (b)(6) 2022 due to respiratory failure.The patient developed respiratory distress at home, followed by seizure like activity.The pump operated as expected and the patient's death was not considered to be device related.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported events and patient outcome, as well as a direct correlation to heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(4), could not be conclusively determined through this evaluation.It was reported that hm3 lvas, serial number (b)(4), would not be returned for evaluation.The hm3 lvas ifu, rev.C, is currently available.Section 1 of the ifu lists respiratory failure, stroke, and death as potential adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 of the ifu, under ¿anticoagulation¿, provides information regarding the recommended anticoagulation therapy and inr range, as well as suggested anticoagulation modifications.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 06 mar 2022.No further information was provided.The manufacturer is closing the file on this event.

• 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: 15096080
• MDR Text Key: 296513197
• Report Number: 2916596-2022-12342
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8354587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: White