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); Tachycardia (2095); Cardiogenic Shock (2262)

Event Date 06/12/2022

Event Type  Death  

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct relationship between heartmate 3 left ventricular assist system (lvas), serial number (b)(4), and the reported events and patient outcome could not be conclusively determined through this evaluation.The device was not returned for evaluation.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 (hm3) left ventricular assist system (lvas) instructions for use (ifu) (rev.C) is currently available.Renal dysfunction, cardiac arrhythmia, and death are listed as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.Additionally, section 6 ¿patient care and management¿ lists arrhythmia as a potential late postimplant complication that may be associated with the use of heartmate 3 lvas.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient's post-operative course was complicated by ventricular tachycardia, renal failure, and cardiogenic shock requiring inotropes and vasopressors.The patient developed progressive renal failure despite optimization of hemodynamics with worsening uremia and metabolic acidosis.The patient was not a candidate for dialysis given his overall critical illness and poor outcome.After discussions with the family, the patient was transitioned to comfort care and the patient passed away.

• 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: 14856713
• MDR Text Key: 294953341
• Report Number: 2916596-2022-11854
• 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: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8437971
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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; Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White