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 Death (1802); Right Ventricular Failure (2055); Sepsis (2067); Shock (2072); Heart Failure/Congestive Heart Failure (4446)

Event Date 12/07/2020

Event Type  Death  

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 through the patient outcome, the patient passed away due to covid, right heart failure, sepsis, and shock.

Event Description

It was reported that there were no devices issues that could have caused or contributed to right heart failure.The device operated as expected.Inotropes, o2 and steriods were initiated.The source of the infection was covid-19.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported event could not be conclusively determined through this evaluation, and a direct correlation with heartmate ii left ventricular assist system (lvas), serial number (b)(6), could not be conclusively established.The patient expired on (b)(6)2020 due to covid-19, right heart failure, sepsis, and shock.The source of the infection was reportedly covid-19, and the patient was treated with inotropes, oxygen, and steroids.It was reported that there were no device issues and the device operated as expected.Heartmate ii lvas, serial number (b)(6), will reportedly not be returned for evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit shipped on (b)(6)2017.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 ¿introduction¿ of this document lists local infection, sepsis, right heart failure, and death as adverse events that may be associated with the use of heartmate ii lvas.Section 6 ¿patient care and management¿ includes information regarding how to prevent and control infection.Section 6 (under "right heart failure") discusses the potential development of right heart failure during use of the heartmate ii lvas and outlines the associated treatment options.The heartmate ii lvas patient handbook contains several sections with information about how to prevent and control 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: 11078026
• MDR Text Key: 223795229
• Report Number: 2916596-2020-06277
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2021

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: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6068458
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/26/2021; 04/13/2021
• Supplement Dates FDA Received: 02/08/2021; 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 96