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 Arrhythmia (1721); Hematoma (1884); Renal Failure (2041); Thromboembolism (2654); Embolism/Embolus (4438); Heart Failure/Congestive Heart Failure (4446); Respiratory Insufficiency (4462)

Event Date 05/18/2021

Event Type  Death  

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 through patient outcome that the patient passed away on (b)(6) 2021 from right ventricular failure.Although death was not considered to be device related patient had medical history of peripartum cardiomyopathy, acute renal failure, ventricular tachycardia, acute iliofemoral clot and popliteal clot required fasciotomy, respiratory failure, leukocytosis, history of pulmonary embolisms, copd, and diabetes.

Manufacturer Narrative

Manufacturer's investigation conclusion: a correlation between the device and the reported peripartum cardiomyopathy, acute renal failure, ventricular tachycardia, acute iliofemoral clot and popliteal clot requiring fasciotomy, respiratory failure, leukocytosis, history of pulmonary embolism, chronic obstructive pulmonary disease, diabetes, and patient outcome could not be conclusively determined during this evaluation.A specific cause for these events could also not be determined.Heartmate 3 left ventricular assist system (lvas), serial number (b)(6), was not explanted 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.Section 1 "introduction" of the heartmate (hm) 3 left ventricular assist system (lvas) instructions for use (ifu) lists the adverse events that may be associated with the use of the heartmate 3 left ventricular assist system, including right heart failure, venous thromboembolism, arterial non-central nervous system thromboembolism, renal dysfunction, arrhythmia, respiratory failure, and death.Section 6 ¿patient care and management¿ lists thromboembolism as a potential late postimplant complication, and also provides the recommended anticoagulation regimen, including the international normalized ratio (inr) range, as well as suggested anticoagulation modifications.This section states that 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.It also lists typical treatment options.This section also lists arrhythmia as a potential late postimplant complication.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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 12417836
• MDR Text Key: 269656756
• Report Number: 2916596-2021-04815
• 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,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7793037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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): Death
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American