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

Model Number 106015

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

Patient Problems Aortic Insufficiency (1715); Death (1802); Hemorrhage/Bleeding (1888); Right Ventricular Dysfunction (2054); Sepsis (2067); Blood Loss (2597); Multiple Organ Failure (3261); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 12/10/2020

Event Type  Death  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is complete.

Event Description

It was reported per the vad coordinator, the patient passed away.It was reported; according to the death summary note, the patient passed away from multi organ dysfunction due to sepsis, ongoing bleeding due to coagulopathy, right ventricular dysfunction plus significant aortic insufficiency requiring pressors.The site confirmed that there was no device related cause of the patient's worsening heart failure.There is no indication the device will be returned for evaluation.

Manufacturer Narrative

Manufacturer investigation conclusion: a direct correlation between (b)(6), and the reported events (sepsis, multisystem organ failure, bleeding, death, and aortic insufficiency) could not be conclusively determined through this investigation.Multiple attempts for additional information, including product return requests, were sent to the account; however, none has been provided at this time.The relevant sections of the device history records were reviewed and showed no deviation from manufacturing or quality assurance specifications.The implant kit shipped on (b)(6) 2016.The heartmate ii left ventricular assist system instructions for use lists sepsis, multiple forms of organ failure, bleeding, and death as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.Instructions regarding preventing infection are outlined in various sections of this document.The instructions for use also warns that moderate to severe aortic insufficiency must be corrected at the time of device implant.The heartmate ii left ventricular assist system patient handbook contains instructions on preventing infection.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: 11091122
• MDR Text Key: 224242608
• Report Number: 2916596-2020-06357
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Weight: 84