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

Model Number 106524INT

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

Patient Problems Stroke/CVA (1770); Thromboembolism (2654)

Event Date 02/17/2021

Event Type  Death  

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 was admitted (b)(6) 2021 for respiratory failure on prolonged period of ventilation and required tracheostomy on (b)(6) 2021.The patient passed away from covid on (b)(6) 2021.A head computed tomography (ct) report from (b)(6) 2021 showed that the patient had right-sided middle cerebral artery territory infarction involving the frontal and parietal lobes.The right posterior cerebral artery territory stroke involved the right occipital lobe, and the left-sided middle cerebral artery infarction involved the superior parietal lobe.

Event Description

Correction: the patient passed away from covid-19 on (b)(6) 2021.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported events (covid-19, respiratory failure, stroke and death), as well as a direct correlation to the heartmate 3 lvas, serial number: (b)(6), could not conclusively be determined through this evaluation.Per additional information from the clinical specialist, the device will not be returned for evaluation.The patient expired on (b)(6) 2021.No product is available 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.The lvas kit was shipped on 09mar2016.The heartmate 3 lvas instructions for use is currently available.Section 1 of this document lists stroke, respiratory failure and death as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.Section 6 of the ifu, ¿patient care and management¿ (under ¿anticoagulation¿), provides information regarding the recommended anticoagulation regimen, including inr values, as well as suggested anticoagulation modifications in the event that 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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12172176
• MDR Text Key: 261648206
• Report Number: 2916596-2021-03901
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2019
• Device Model Number: 106524INT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 61 YR
• Patient Weight: 49