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); Intracranial Hemorrhage (1891); Sepsis (2067); Embolism/Embolus (4438)

Event Date 06/18/2022

Event Type  Death  

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(4), and the reported events could not be conclusively determined through this evaluation.The heartmate 3 lvad, serial number (b)(4), 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 implant kit was shipped on 15 jun 2021.The heartmate 3 lvas ifu is currently available.Section 1 ¿introduction¿ of this document lists infection, sepsis, stroke, and death as adverse events that may be associated with the use of the heartmate 3 lvas.Care instructions in regard to preventing infection are provided in various sections of the ifu, including caring for the driveline exit site and controlling infection.The heartmate 3 lvas patient handbook is also available at the time of implant.Several sections of this handbook provide care instructions in regards to preventing infection.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient passed away due to sepsis.The patient was admitted on (b)(6) 2022 with altered mental status.Computerized tomography confirmed small acute/subacute subarachnoid hemorrhage in the high left central sulcus.No treatment was done for the bleed.Positron emission tomography (pet) scan revealed multiple areas of abnormal uptake near the device outflow tract, implantable cardioverter-defibrillator (icd) leads as well as small bowel concerning for septic embolism.Icd removal was determined to be too high risk.This was treated with antibiotics.Patient had ongoing bacteremia (onset date of (b)(6) 2022) and failure to thrive, patient was transitioned to comfort measures only.Blood cultures came back positive for staphylococcus epidermidis and infection was treated by intravenous antibiotics.Patient had increased oxygen requirements and passed away on (b)(6) 2022.The death was not considered to be device related and the device operated as expected.Device will not be returned for evaluation.

• 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: 15112118
• MDR Text Key: 296670329
• Report Number: 2916596-2022-12317
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2022

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: 12/05/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8000479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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; Death; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Race: White