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 Cardiogenic Shock (2262); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/10/2022

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 the patient had a severe right ventricular dysfunction despite inotropic therapy.They remained unstable presenting cardiogenic shock and lactic acidosis that became refractory that cause multisystem organ failure and then death.

Manufacturer Narrative

Section a2: patient date of birth was inadvertently added in initial report and should have been removed due to patient privacy laws.Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events of right heart failure, multi-system organ failure, as well as the subsequent patient outcome could not be conclusively established through this evaluation.The device was not returned for evaluation.Multiple attempts were made to obtain additional information from the customer regarding the event (including requests for product return); however, no additional information was provided.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specification.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), is currently available.Section 1 of the ifu, ¿introduction¿, lists right heart failure, multiple organ failures/dysfunctions, and death as adverse events that may be associated with the use of the heartmate 3 lvas.No further information was provided.The manufacturer's investigation is complete.

Event Description

Correction: right ventricular dysfunction started (b)(6) 2022.The patient passed away on (b)(6) 2022.

Event Description

Additional information: it was reported that the right ventricular dysfunction started on (b)(6) 2022.

Manufacturer Narrative

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: 14886924
• MDR Text Key: 295131081
• Report Number: 2916596-2022-12061
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/15/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8217096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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 Age: 52 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Hispanic
• Patient Race: White