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

Model Number 106524US

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

Patient Problems Stroke/CVA (1770); Convulsion/Seizure (4406); Heart Failure/Congestive Heart Failure (4446); Unspecified Heart Problem (4454)

Event Date 09/02/2021

Event Type  Death  

Manufacturer Narrative

The patient's initials were not provided.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient was admitted to the hospital with decompensated heart failure on (b)(6) 2021, and presented to the operating room on (b)(6) 2021 for implant of heartmate 3 by a left lateral thoracotomy approach.Prior to coming to the operating room he was placed on an intra-aortic balloon pump (iabp).The heartmate 3 was implanted and it was noted on the transesophageal echocardiogram (tee) that there were large amounts of air that was coming from the left ventricle (lv) apex area.Multiple attempts were made to address if a bleeding concern and adjust the pump with no resolution of the air in the lv.The large amount of air were a concern that the pump was not properly locked and/or possibly damaged.A sterile mini cuff was opened and tested to see if could properly lock and again it was noted that a very small (~1 cm) portion of the locking mechanism was visible on the left side (10/11 o'clock) of the pump and there was no yellow visual.This was the same that was noticed before.A decision was made while in the operating room and not able to get off by-pass to exchange the pump.Then the second heartmate 3 pump attached to the initial apical cuff with no additional air in the left ventricle.Once the second pump was weaned off by pass it appeared to correct the air entrapment that was seen on tee.Unfortunately the right ventricle was not doing well and the patient was placed on fem/ fem venoarterial extracorporeal membrane oxygenation (va-ecmo) to provide additional hemodynamic support.The chest was left open and the patient returned to the icu.On (b)(6) 2021 the chest was washed out and closed but remained on va-ecmo.It has been reported (b)(6)2021 that the patient has responded to pain only and not following commands and has continued to have seizures.Patient remained hemodynamically stable and there were no concerns with the operation of the heartmate 3.Since patient was unable to wean off va ecmo.Multiple family meetings occurred with the healthcare team and a decision to withdrawal support was made on (b)(6) 2021.No autopsy was performed, and the pump was not explanted.Related manufacturer report number of first pump: 2916596-2021-05332.

Event Description

It was reported that the patient had a head computed tomography (ct) scan on (b)(6) 2021 that revealed a questionable small infarct in the left anterior frontal lobe of an uncertain age.

Manufacturer Narrative

Section b5: the information regarding (b)(6) 2021 ct scan results was originally reported in related manufacturer report numbers: 2916596-2021-05495 and 2916596-2021-05725.Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6) , and the reported event could not conclusively be established through this evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6) 2021.The heartmate 3 lvas instruction for use (ifu), rev.C, is currently available.Section 1 of this document lists right heart failure, stroke, other neurological event (not stroke-related), and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 entitled ¿patient care and management¿ also lists neurological dysfunction as a potential late postimplant complication.Section 6 "patient care and management" (under "right heart failure") discusses the potential development of right heart failure following implant and outlines the associated treatment options, including right ventricular assist device (rvad) placement.Section 6 (under caution!) states: "right heart failure can occur following implantation of the pump.Right ventricular dysfunction, especially when combined with elevated pulmonary vascular resistance, may limit the effectiveness of the left ventricular assist system due to reduced filling of the pump." section 6 ¿patient care and management¿ (under "anticoagulation") also outlines the recommended anticoagulation regimen (including international normalized ratio (inr) range) for patients using the heartmate 3 lvas as well as the suggested anticoagulation modifications.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 (ASSISST) 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: 12564999
• MDR Text Key: 274418937
• Report Number: 2916596-2021-05766
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7955674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• 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): Hospitalization; Required Intervention; Death
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Hispanic
• Patient Race: White