MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAD; VENTRICULAR (ASSISST) BYPASS

Model Number 106523

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

Patient Problems Death (1802); No Information (3190)

Event Date 12/15/2019

Event Type  Death  

Manufacturer Narrative

The heartmate 3 lvas was implanted during the momentum 3 clinical trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23aug2017.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).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 passed away.Cause of death was listed as other.No additional information was provided.

Manufacturer Narrative

Section d4: additional information.Section h4: additional information.Manufacturer's investigation conclusion: a specific cause for the patient outcome, as well as a direct correlation to heartmate 3 lvas, serial number (b)(6), could not conclusively be determined through this evaluation.It was reported that the patient expired on (b)(6) 2019.Multiple attempted to gather additional information was attempted; however, none was provided.No product is available for investigation.The heartmate 3 lvas ifu lists death as an adverse event that may be associated with the use of heartmate 3 left ventricular assist system.The relevant device history records for (b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on (b)(6) 2020.The heartmate 3 lvas ifu document is currently available.This ifu lists death as an adverse event that may be associated with the use of heartmate 3 left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAD
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10969838
• MDR Text Key: 220276927
• Report Number: 2916596-2020-06154
• 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: health professional,study
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2015
• Device Model Number: 106523
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 71 YR