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 Arrhythmia (1721); Hematoma (1884); Hemorrhage/Bleeding (1888); Ventricular Fibrillation (2130); Numbness (2415); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/01/2022

Event Type  Injury  

Event Description

It was reported that the patient required defibrillation while in the operating room (or) prior to receiving right ventricular assist device (rvad) support using a centrimag.Following rvad placement, the patient required cardioversion; the arrhythmia resolved before the patient left the operating room.The patient had a history of both supraventricular tachycardia (svt) and right heart failure prior to their device implant.The patient was given a blood transfusion on (b)(6) 2022 following a decrease in their hemoglobin levels post-operatively associated with the output of their chest tube.On (b)(6) 2022, the centrimag console emitted "whirring" sounds and the screen went blank.The console was successfully exchanged with no adverse patient impact.Another blood transfusion was given on (b)(6) 2022 as their hemoglobin levels had not yet increased.The patient's chest tube output was noted to be less than 2 liters over a 24 hour period.On (b)(6) 2022, the patient was noted to have a possible atrial flutter with their heart rate in the 140s.The patient was given anti-arrhythmia medication both orally and intravenously, and was cardioverted, which resolved the event on (b)(6) 2022.The patient received another blood transfusion on (b)(6) 2022.On (b)(6) 2022, the patient underwent a left brachial artery exploration and repair.An expanding hematoma and hand numbness were noted following the placement of a left brachial arterial line.The patient was given an additional blood transfusion on (b)(6) 2022, although no active bleeding was noted.Another blood transfusion was given on (b)(6) 2022.Related centrimag blood pump mfr#: 3003306248-2022-11275 related centrimag console mfr#: 3003306248-2022-11278.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was additionally reported on (b)(6) 2022 that the patient experienced pain in their left upper extremities on (b)(6) 2022; a duplex venous scan was performed that confirmed evidence of an acute, nonocclusive deep venous thrombus involving a focal segment of the left internal jugular vein.No actions were taken as the patient was already anticoagulated.The patient's hematoma was considered resolved on (b)(6) 2022.The patient experienced an episode of ventricular fibrillation (vf) on (b)(6) 2022; the patient was given anti-tachycardia pacing (atp) therapy and the issue resolved.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events, as well as a direct correlation to the heartmate 3 left ventricular assist system (lvas), serial number: (b)(6), could not conclusively be determined through this evaluation.The relevant sections of the device history records for (b)(6) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on 11may2022.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) (rev.C) lists bleeding, cardiac arrhythmia, and venous thromboembolism as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.This document also provides information regarding anticoagulation, including recommended inr values.Section 5 "surgical procedures" (under ¿preparing the ventricular apex site¿) instructs to inspect the ventricular chamber for mural thrombi and crossing trabeculae following removal of the core and to address one or both, as needed.This section also states that pump function will be compromised in the presence of inlet obstruction.Section 5 (under ¿implant procedures¿) additionally warns to inspect the ventricle and remove any previously formed clots that may cause embolism or any trabeculae that may impede flow.Section 6 "patient care and management" (under "anticoagulation") contains information regarding the recommended anticoagulation therapy for patients using the device.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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14978568
• MDR Text Key: 295632343
• Report Number: 2916596-2022-12125
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/05/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8458962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• 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: 39 YR
• Patient Sex: Male
• Patient Weight: 115 KG