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

Model Number 106524US

Device Problems Failure to Align (2522); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 04/28/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient was taken back to the or (operating room) due to inflow cannula position pointed towards the septum, which was diagnosed by x-ray.The clinician observed the surgeon place sutures around the outflow bend relief and tact to diaphragm, as well as a suture in the bend relief and tack to chest wall.The clinician observed the or team utilizing echo (echocardiogram) for optimization of inflow position.The cannula was observed to be parallel with the septum in the left ventricle.The chest was closed and the patient was transferred to the intensive care unit (icu).The pump components operated as intended.It was reported on (b)(6) 2022 that the patient was improving, extubated, with stable flows.A right ventricular assist device (rvad) was implanted due to post operative rv (right ventricle) failure.The rvad was a maquet pump and circuit without an oxygenator.On (b)(6) 2022 it was reported that the patient's right heart failure improved after support, with echo showing normal values.It was also reported that the patient's rvad was discontinued the previous day due to recovery.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of the inflow cannula being positioned towards the septum could not be confirmed through the submitted x-ray image.Additionally, a direct correlation between the reported right ventricular (rv) failure and the device could not be conclusively established through this evaluation.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6).No further events have been reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu) is currently available.Section 1, "introduction," lists right heart failure as an adverse event that may be associated with the use of heartmate 3 lvas.Section 5 entitled ¿surgical procedures¿ explains how to insert the pump in the ventricle and instructs the user to take care to avoid orienting the inlet towards the interventricular septum.Pump function will be compromised in the presence of inlet obstruction.This section also outlines the steps to reorient the pump.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: 14455413
• MDR Text Key: 292171423
• Report Number: 2916596-2022-10746
• 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
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8341062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American