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

Model Number 106524US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Atrial Fibrillation (1729); Encephalopathy (1833); Hemorrhage/Bleeding (1888); Shaking/Tremors (2515); Thromboembolism (2654); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 10/22/2021

Event Type  Injury  

Event Description

It was reported on (b)(6) 2021 that the patient had cardiac arrhythmia starting on (b)(6) 2021, which may have been possibly related to ventricular assist device (vad) therapy.The patient was treated with intravenous amiodarone.It was reported on (b)(6) 2021 that the patient was cardioverted on (b)(6) 2021 but then returned to atrial fibrillation (afib) the next morning.The patient reportedly had intermittent paroxysmal afib prior to implant even though the event began on (b)(6) 2021.It was reported on (b)(6) 2021 that the patient developed anemia from an unknown bleeding source and received one unit of packed red blood cells (prbcs) on this day.It was reported on (b)(6) 2021 that the patient had right heart failure (rhf) starting on (b)(6) 2021.The patient had been put on inotropes on (b)(6) 2021 and remained on inotropes as of (b)(6) 2021.It was reported on (b)(6) 2021 that the patient had a deep vein thrombosis (dvt) in their left arm in the axillary vein around their peripherally inserted central catheter (picc) line.The patient was not treated for the dvt.It was further reported on (b)(6) 2021 that the arrhythmia had not resulted in any clinical compromise and the patient's implanted cardioverter-defibrillator (icd) was implanted prior to heartmate therapy.A device related issue was not reported to have contributed to the patient's rhf.The patient was asymptomatic and their rhf was treated with inotropes which they had since stopped.The patient's thrombus was reported to have formed due to their picc line and was unrelated to anticoagulation or patient condition.As of (b)(6) 2021, the patient was out of the cardiovascular intensive care unit (cvicu) and their deep vein thrombosis (dvt) was gradually dissolving.It was reported on (b)(6) 2021 that the patient had developed metabolic encephalopathy that was unlikely to be device-related.

Manufacturer Narrative

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

Event Description

Additional information: it was reported that the metabolic encephalopathy resolved on 04nov2021.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system, serial number (b)(6), and the reported events (peripheral thrombus, bleeding, neurological dysfunction, cardiac arrhythmia, and right heart failure) could not be conclusively determined through this investigation.The patient was implanted with heartmate 3 left ventricular assist system, serial number (b)(6), on (b)(6)2021 and underwent a complicated post-implant course.The patient remains ongoing on heartmate 3 left ventricular assist system, serial number (b)(6).The relevant sections of the device history records were reviewed and showed no deviation from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system instructions for use, rev.C, is currently available and contains the following information: section 1 lists cardiac arrhythmia, thromboembolism, bleeding, right heart failure, and other neurological event (not stroke-related) as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.Section 6 states: "right heart failure can occur following implantation of the pump.Right ventricular dysfunction, especially when combined with elevated pulmonary vascular resistance, may limit the effectiveness of the left ventricular assist system due to reduced filling of the pump." this section also lists cardiac arrhythmia, thromboembolism, and neurological dysfunction as potential late post-implant complications that may be associated with the use of the heartmate 3 left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient experienced symptoms of tingling extremities and tremors/shaking on (b)(6) 2021.The patient also complained of fatigue post procedure as well as pain in the surgical site.The patient experienced shortness of breath and weight gain on (b)(6) 2021.Complaints of dizziness, weakness, and the patient's vision "jumping" were also reported.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas (left ventricular assist system), serial number (b)(6), and the reported events could not be conclusively determined through this investigation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).The relevant sections of the device history records for (b)(6) were reviewed and showed no deviation from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system instructions for use, rev.C, is currently available and contains the following information: section 1 lists cardiac arrhythmia, thromboembolism, bleeding, right heart failure, and other neurological event (not stroke-related) as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.Section 6 states: "right heart failure can occur following implantation of the pump.Right ventricular dysfunction, especially when combined with elevated pulmonary vascular resistance, may limit the effectiveness of the left ventricular assist system due to reduced filling of the pump." this section also lists cardiac arrhythmia, thromboembolism, and neurological dysfunction as potential late postimplant complications that may be associated with the use of the heartmate 3 left ventricular assist system.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
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 12842846
• MDR Text Key: 280999677
• Report Number: 2916596-2021-06652
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/16/2024

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: Health Professional
• Device Expiration Date: 01/20/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8167496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 01/14/2022; 08/15/2023; 04/24/2024
• Supplement Dates FDA Received: 01/20/2022; 09/07/2023; 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 117 KG