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 Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 03/21/2024

Event Type  Injury  

Event Description

It was reported that the patient returned to the operating room for sternal mediastinal exploration and hematoma evacuation.The patient had 2 liters of chest tube output and "extreme" hypotension.Chest radiography showed mild cardiomegaly that persisted with slightly higher diaphragms and slightly increased density at both lung bases which could represent any combination of airspace consolidation or effusions especially on the right.The sternal exploration showed that there was a moderate number of clots along the right atrium and a large number of clots were evacuated from the sternum.Focal bleeding site along the pericardial reflection near the superior vena cava and two sites along the aortic fat that were sutured was also reported.The patient was also treated with multiple blood products.There was no change to anticoagulation status or pump parameters that contributed to bleeding and clot formation.Per the ventricular assist device coordinator, there was nothing on the outflow graft site or pump itself that caused this issue.The patient returned to the intensive care unit and was later extubated, as their condition had improved.The plan was to continue care until eventual discharge home.There were no reported alarms.The device operated as intended.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), and the reported bleeding could not be conclusively established through this evaluation.The patient remains ongoing on the heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), with no further events 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 (hm) 3 left ventricular assist system (lvas) instructions for use (ifu) rev.C is currently available.Section 1, ¿introduction¿, lists potential adverse events, including bleeding that may be associated with the use of the hm3 lvas.Additionally, section 6, "patient care and management", provides information regarding the recommended anticoagulation regimen, including international normalized ratio (inr) values, as well as suggested anticoagulation modifications in the event there is a risk of bleeding.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 19004473
• MDR Text Key: 338916432
• Report Number: 2916596-2024-01870
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106524US
• Device Lot Number: 10052739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2023
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Hispanic
• Patient Race: White