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 Pleural Effusion (2010); Heart Failure/Congestive Heart Failure (4446)

Event Date 07/15/2021

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 had large left pleural effusion which required drainage via chest drain insertion.The patient had symptoms and signs of persistent right heart failure requiring inotropes.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported events, as well as a direct correlation to heartmate 3 left ventricular assist system (lvas), serial number (b)(6), could not conclusively be determined through this evaluation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).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 (b)(6) 2020.The heartmate 3 lvas ifu is currently available.Section 1 of the ifu, ¿introduction¿, lists right heart failure as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 of the ifu, ¿patient care and management¿ (under ¿right heart failure), states that patients may develop right ventricular failure during or shortly after implant and outlines the associated treatment options.Additionally, section 6, under ¿caution!¿, explains 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.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: 12275862
• MDR Text Key: 265013649
• Report Number: 2916596-2021-04115
• 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: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: 106524INT
• Device Lot Number: 7716600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 75