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 Hematoma (1884); Unspecified Infection (1930); Blood Loss (2597)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

Related mfr: 2916596-2020-06171.Related mfr: 2916596-2020-06178.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient had a hematoma of the crt-d site with suspicion of the outflow graft infection.The crt-d was extracted on (b)(6) 2020.It was reported that having the device extracted did not resolve the issue.This was reported to being possibly related to a prior driveline infection.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the reported events (infection, bleeding) and heartmate 3 left ventricular assist system (hm3 lvas), serial number (b)(6) could not be conclusively established through this evaluation.A specific cause for the reported events could not be conclusively determined through this evaluation.The center reported that the patient experienced hematoma of the crt-d (cardiac resynchronization therapy defibrillator) site with the suspicion of ogf (outflow graft) infection.The start date was listed as (b)(6) 2020.The crt-d was extracted on (b)(6) 2020 in the operating room, and infection of the crt-d site was confirmed.The event was reported as possibly related to the device.No alarms were reported for this event.The patient ultimately expired on (b)(6) 2020 (manufacturer report number: 2916596-2020-06178).Hm3 lvas, serial number (b)(6) was not explanted 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 was shipped on (b)(6) 2016.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.The heartmate 3 lvas instructions for use (ifu) is currently available.Section 1 of this ifu lists infection (local, driveline and pump pocket) and bleeding as adverse events that may be associated with the use of the hm3 lvas.Care instructions in regard to preventing infection are provided in various sections of this ifu, including a section entitled "controlling infection." section 6 provides information regarding anticoagulation, including the recommended international normalized ratio (inr) values.The hm3 lvas patient handbook is also currently available.This handbook also contains information about preventing infection.No further information was provided.The manufacturer is closing the file on 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: 11173041
• MDR Text Key: 227005015
• Report Number: 2916596-2021-00152
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Model Number: 106524INT
• Device Lot Number: 5547631
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention