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

Model Number 106524US

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423)

Patient Problems Embolism (1829); Fever (1858); Headache (1880); Unspecified Infection (1930); Thrombus (2101); Obstruction/Occlusion (2422); Hemorrhagic Stroke (4417); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Skin Infection (4544)

Event Date 11/21/2020

Event Type  Injury  

Manufacturer Narrative

The results/method/conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient was admitted from (b)(6) 2020 to (b)(6) 2020 due to a chronic pseudomonas driveline infection.The patient had symptoms of chills, rigors, and fevers.A driveline revision was performed and the velour layer was removed on (b)(6) 2020.Antibiotics were administered per incision and drainage.On (b)(6) 2020, the patient experienced a suspected embolic stroke with hemorrhagic conversion.The patient's anticoagulation medication was held for one day per the recommendation of the neurology department.On (b)(6) 2020, a head computed tomography (ct) scan was performed due to the patient's complaints of a headache.The patient was stable with headache as the only symptom.The site followed up with another ct scan and a transesophageal echocardiogram to assess for vegetation.The echocardiogram revealed a large mobile echodensity within the heartmate device's inflow cannula indicating a thrombus, clot, or vegetation.There were no changes in pump power to indicate thrombus in the pump.The site reported that the patient's recent experiences of infection and having anticoagulants stopped due to the stroke may have contributed to thrombus formation.There were no unusual events recorded in the log file event history.The mechanical device was operating as intended.The pump parameters and trending were not typical for suspected thrombus or obstruction.The patient had no further symptoms, was restarted on anticoagulation medication, and was discharged home on suppressive antibiotics.

Manufacturer Narrative

Manufacturer investigation conclusion: the report of a suspected thrombus could not be confirmed through this investigation, as no product or images were submitted.Additionally, a specific cause for the reported driveline infection and stroke, as well as a direct correlation to heartmate 3 left ventricular assist system (lvas), serial number (b)(6), could not be conclusively established.The submitted controller event log file captured no atypical events or alarms.The system appeared to be operating as intended at the set speed for the duration of the file.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6), and no further related 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 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 ¿introduction¿ of this document lists pump thrombosis, stroke, bleeding and infection as adverse events that may be associated with the use of heartmate 3 lvas.Section 6, ¿patient care and management¿, also lists thromboembolism as a potential late postimplant complication.Additionally, this section, under ¿anticoagulation¿, provides the recommended anticoagulation regimen, including international normalized ratio (inr) values, as well as suggested anticoagulation modifications.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.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11159134
• MDR Text Key: 226553734
• Report Number: 2916596-2020-06446
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/25/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6785103
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 81