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 Sepsis (2067); Septic Shock (2068); Cardiogenic Shock (2262)

Event Date 06/17/2021

Event Type  Death  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient passed away from cardiogenic shock and sepsis.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the patient¿s sepsis could not be conclusively determined through this evaluation.Furthermore, a direct correlation between heartmate ii lvas (b)(6) and the reported events could not be determined through this investigation multiple attempts were made to obtain additional information regarding the reported events as well as the pump¿s return status; however, no further information was provided by the account and no product has been returned to date.If heartmate ii left ventricular assist system, serial number (b)(6), is returned at a later date, this investigation may be reopened to include the evaluation of the device.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 was shipped on 11apr2017 via customer order.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section ¿introduction¿ of this document lists adverse events that may be associated with the use of the heartmate ii lvas, including sepsis and death.Although only sepsis was reported by the account, the ifu also lists infection as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system.The ifu also contains information on controlling infection in the patient care and management section.No further information 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
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 12530903
• MDR Text Key: 273286666
• Report Number: 2916596-2021-05045
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 5941729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Death
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 79 KG