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 Bacterial Infection (1735); Dehydration (1807); Unspecified Infection (1930); Nausea (1970); Weight Changes (2607); Skin Infection (4544)

Event Date 04/16/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced lowered pulsatility index (pi) pressure with flow and power normal.Patient was recommended to increase fluid intake.Patient denies lightheadedness, shortness of breath, edema, or alarms.Mean arterial pressure (map) was normal throughout.A routine appointment and labs scheduled for (b)(6) 2022.On (b)(6) 2022, the patient was noted to have continually fluctuating pi with episodes of nausea.On (b)(6) 2022, the patient reported their left thoracotomy incision opening with drainage present.They were admitted to the hospital with iv antibiotics.Blood cultures came back positive for enterococcus faecalis.On (b)(6) 2022, picc line was placed for long term iv antibacterial therapy at home.A positron emission tomography (pet) scan was scheduled to determine if the implantable cardioverter-defibrillator (icd) is the cause of the infection.The scan will also determine if the pump is also infected.

Manufacturer Narrative

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

Event Description

On (b)(6) 2022 a positron emission tomography (pet) scan was performed and moderate uptake around the pump and outflow cannula was seen.New uptake was noted around the patient's driveline.Post surgical changes versus infection etiology were considered.An incision and drainage procedure was performed and a wound vac was placed on the patient's thoracotomy site.The patient's infection would be reassessed to see if an early transplant listing would be required.On (b)(6) 2022 the patient had a cardiothoracic surgery appointment and was noted to be improving with negative cultures and no signs of purulent drainage.On (b)(6) 2022 the patient's jp drain was removed.The patient's infection resolved without sequelae on (b)(6) 2022.The pi pressure drop the patient had experienced was due to hypovolemia.The left ventricular assist system (lvas) was operating as intended.The patient was stable and would be seen for routine follow ups.On (b)(6) 2022 it was reported that the patient gained (b)(4) with a map of (b)(4).The patient's losartan was decreased to 12.5 daily.No dizziness reported by the patient, diuretics were decreased and diet restrictions provided.

Manufacturer Narrative

Section a- date of birth: patient privacy laws prohibit the release of private patient information and the patient's date of birth should have been removed from the previous report.Manufacturer's investigation conclusion: a direct correlation between the reported events and the device could not be conclusively determined through this evaluation.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6).No product is available for investigation.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 infection as adverse event which may be associated with the use of heartmate 3 lvas.Section 6, "patient care and management," lists hypovolemia as a potential late postimplant complication.The heartmate 3 lvas patient handbook is also currently available.Both the ifu and patient handbook contain various sections regarding infection and how to prevent it.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: 14347525
• MDR Text Key: 291317216
• Report Number: 2916596-2022-10683
• 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: 08/05/2022

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: 11/09/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8123474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 07/13/2022
• Supplement Dates FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2021
• 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; Life Threatening
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 82 KG