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

Model Number 106524US

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Arrhythmia (1721); Ventricular Tachycardia (2132)

Event Date 12/15/2019

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 was transplanted.The patient was uplisted due to recurring ventricular tachycardia and no longer required circulatory support.It was further reported that the arrhythmia might have been caused by possible positional issues from initial surgeries.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the reported ventricular tachycardia could not be determined through this evaluation.The patient underwent a transplant on (b)(6) 2019.The patient was experiencing recurring ventricular tachycardia that the account believed may have been caused by possible positional issues from initial surgeries.It was also reported that the patient no longer required circulatory support, and that there were no device issues or malfunctions.(b)(6) was not returned for investigation.The heartmate 3 lvas ifu lists cardiac arrhythmia as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of this ifu lists cardiac arrhythmia as an adverse event that may be associated with the use of the heartmate 3 lvas.Section 6 of this ifu lists arrhythmia as a potential late postimplant complication.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 95488
• MDR Report Key: 9830984
• MDR Text Key: 184428966
• Report Number: 2916596-2020-01350
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 05/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6860390
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 105