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 Renal Failure (2041); Multiple Organ Failure (3261); Heart Failure/Congestive Heart Failure (4446)

Event Date 02/08/2024

Event Type  Death  

Event Description

It was reported that the patient was admitted due to acute right ventricular (rv) failure on (b)(6) 2024, which existed prior to left ventricular assist device (lvad) implantation.The patient was given vasopressin and norepinephrine that was complicated by acute renal failure, which required continuous renal replacement therapy (crrt).While still inpatient, the patient was noted to be critically sick lacking meaningful alertness or interactions on (b)(6) 2024.Once stabilized, the patient never regained meaningful interaction or alertness.Rv failure and renal failure resulted in patient decline due to multiorgan system failure.The patient was made do-not-resuscitate and dialysis was stopped on (b)(6) 2024.The patient was placed on comfort care and the decision was made on (b)(6) 2024 by the patient's family to withdraw lvad support.The patient passed away on (b)(6) 2024 after the lvad was turned off.No autopsy was performed and the lvad was not explanted.The clinician deemed the patient's death to not be lvad related, as the device was functioning as intended at the patient's time of death.

Manufacturer Narrative

No further information provided.A supplemental report will be submitted once the manufacturer investigation is complete.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 19002793
• MDR Text Key: 338888003
• Report Number: 2916596-2024-01821
• 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 Practitioner
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106524US
• Device Lot Number: 9151063
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2023
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White