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

Model Number 106524INT

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

Patient Problems Ischemia (1942); Heart Failure/Congestive Heart Failure (4446)

Event Date 05/10/2022

Event Type  Death  

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(4), and the reported right heart failure, mesenteric ischemia, and patient outcome could not be conclusively established through this evaluation.The hospital refused requests for additional information regarding the patient outcome due to patient privacy laws.(b)(4) was not explanted for evaluation.The patient outcome was not considered to be device or therapy related.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), is currently available.Section 1 ¿introduction¿ of this document lists right heart failure and death as adverse events that may be associated with the use of the heartmate 3 lvas.Additionally, section 6 ¿patient care and management¿ lists right heart failure as a potential risk/adverse event that may be associated with the use of heartmate 3 lvas.This section (under ¿right heart failure¿) also outlines indications of right heart failure as well as possible treatments.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient passed away on (b)(6) 2022 due to mesenteric ischemia.It was also noted that the patient developed right heart failure post implant and that the outcome was not device or therapy related.

• 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: 14518439
• MDR Text Key: 292785470
• Report Number: 2916596-2022-11019
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/11/2023
• Device Model Number: 106524INT
• Device Lot Number: 8255299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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 Sex: Female