MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524INT

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

Patient Problems Aspiration/Inhalation (1725); Death (1802); Hemorrhage/Bleeding (1888); Hypoxia (1918); Blood Loss (2597)

Event Date 12/24/2020

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the full report.

Event Description

It was reported that the patient expired due to hypoxia after aspirating on (b)(6) 2020.The patient aspirated blood after oral bleeding.Privacy laws prohibit the customer from providing information regarding the case.No autopsy was performed.The device was not explanted.The device will not be returned for evaluation.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the device and the patient¿s expiration cannot conclusively be determined through this investigation.No product available for investigation.The relevant section of the device history records for (b)(6), were reviewed and showed no deviations from manufacturing or qa specifications.The implant kit was shipped on (b)(6) 2020.The heartmate 3 lvas ifu is currently available.Section 1 of this document lists bleeding and death as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.The patient care and management section provides information regarding anticoagulation, including the recommended international normalized ratio (inr) values.No further information was provided.The manufacturer is closing this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11141147
• MDR Text Key: 225814337
• Report Number: 2916596-2021-00067
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

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: 06/02/2023
• Device Model Number: 106524INT
• Device Lot Number: 7580967
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death