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 Cardiac Arrest (1762); Stroke/CVA (1770); Thromboembolism (2654); Heart Failure/Congestive Heart Failure (4446)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient experienced adverse events post-operation.On (b)(6) 2021, the patient went into cardiac arrest upon returning from the operating room which believed to be from rv (right ventricular) failure.Chest compressions were done, and patient returned to the operating room (or) for protekduo with centrimag and oxygenator for right sided support.On (b)(6) 2021, it was reported the patient spontaneously moved right side; unable to move left side.Code 1 (stroke) called but outside possible window for intervention-head ct (computed tomography) showed multiple strokes: right middle cerebral artery (mca) and aca (anterior cerebral artery), l mca likely embolic in nature.On (b)(6) 2021, the patient experienced episode of not moving rue.Code 1 called again-outside intervention window.The patient was following commands only on the right side.Continued to move left foot spontaneously (intermittent twitches).The patient would continue to be monitored during recovery.No additional information provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the reported events could not be conclusively determined through this evaluation.The account communicated that the patient went into cardiac arrest upon returning from the operating room (or) believed to be due to right ventricular (rv) failure.Chest compressions were done, and the patient returned to the (or).On (b)(6) 2021, the account reported the patient spontaneously moved the right side and was unable to move the left side.Code 1 (stroke) called and head computed tomography (ct) showed multiple strokes including right middle cerebral artery (mca), anterior cerebral artery (aca), and left mca likely embolic in nature.On (b)(6) 2021, the patient experienced an episode of not moving the right upper extremity (rue), and code 1 was called again outside the intervention window.The account later communicated that the patient was following commands only on the right side and continued to move their left foot spontaneously.The patient would continue to be monitored during recovery.The patient ultimately expired on 16jul2021.The heartmate 3 lvad, serial number (b)(6), was not returned for analysis (refer to manufacturer report number 2916596-2021-04087).The heartmate 3 lvas ifu, rev.C, lists right heart failure and stroke as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 entitled ¿patient care and management¿ provides information regarding anticoagulation, including recommended inr values, and the suggested anticoagulation modifications in the event that there is a risk of bleeding.Section 6 also cautions the user that right heart failure can occur following implantation of the pump and outlines the associated treatment options.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The relevant sections of the device history records for the percutaneous lead were also reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 04may2021.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: 12089486
• MDR Text Key: 263479911
• Report Number: 2916596-2021-03203
• 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: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/03/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7932457
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 138