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 Anemia (1706); Dyspnea (1816); Headache (1880); Unspecified Infection (1930); Nausea (1970); Presyncope (4410)

Event Date 07/11/2022

Event Type  Injury  

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 was seen in the er for weakness, shortness of breath, nausea, vomiting, lightheadedness and seeing spots, they also had a headache in the setting of a supratherapeutic international normalized ratio (inr).The patient also had enterococcus bacteremia where the source of infection was unclear.The patient was admitted and was given ampicillin for the continuous infection.A blood transfusion was required due to anemia without evidence of blood loss.Chest x-ray, computed tomography (ct) of the chest, abdomen, and pelvis was done.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported infection could not conclusively be determined through this evaluation.A direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events could not conclusively be established through this evaluation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6), and no further related events have been reported at this time.The heartmate 3 lvas instructions for use (ifu) lists infection, bleeding, and respiratory failure as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.The ifu provides the recommended anticoagulation regimen, including inr range, as well as suggested anticoagulation modifications in the event that there is a risk of bleeding.Additionally, the heartmate 3 ifu and patient handbook provide care instructions regarding how to prevent infection as well as suggested responses in the event of infection 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 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of this ifu lists infection, bleeding, and respiratory failure as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 ¿patient care and management¿ (under "anticoagulation") outlines the recommended anticoagulation regimen (including inr range) for patients using the heartmate 3 lvas as well as the suggested anticoagulation modifications in the event that there is a risk of bleeding.Care instructions in regard to preventing infection are provided in various sections of this ifu, including a section entitled "controlling infection." the heartmate 3 lvas patient handbook is also currently available.This handbook also contains information about preventing infection.No further information was provided.The manufacturer is closing the file on this event.

Event Description

In the emergency department the patient had acute respiratory failure with hypoxia requiring supplemental oxygen.The patient had diffuse crackles bilaterally with lower trace extremity edema.The patient was also complaining of a worsening headache.The patient was also reported to have chronic heart failure.The patient's infection and respiratory failure reportedly resolved without sequelae on (b)(6) 2022.

• 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: 15133376
• MDR Text Key: 296914209
• Report Number: 2916596-2022-12407
• 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
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/05/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8507941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 85 KG