MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 104911

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

Patient Problems Aortic Regurgitation (1716); Right Ventricular Dysfunction (2054)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

Event date estimated.Date of imaging used.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

(b)(6) 2020 echo revealed mild continuous aortic regurgitation.Right ventricular cavity size was mildly dilated with mildly decreased right ventricular systolic function.La moderately dilated.There was mild dilatation of the ascending aorta.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between (b)(6) and the reported right heart failure and regurgitation could not be conclusively determined through this evaluation.Multiple requests for additional information regarding this event were submitted to the account; no response has been received at this time.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) lists right heart failure as a possible adverse event associated with the use of hmii therapy.This document also warns that moderate to severe aortic insufficiency must be corrected at time of device implant.The patent remains ongoing on (b)(6).Heartmate ii (hmii) left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of this document lists right heart failure as a possible adverse event associated with the use of hmii therapy.Section 5 "surgical procedures" warns that moderate to severe aortic insufficiency must be corrected at time of device implant.Section 6 ¿patient care and management¿ describes that right heart failure can occur post-implant and provides strategies for treating patients who experience right heart failure.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10401313
• MDR Text Key: 202710301
• Report Number: 2916596-2020-03958
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: 00813024011170
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2013
• Device Model Number: 104911
• Device Catalogue Number: 104911
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 97