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 Anemia (1706); Bacterial Infection (1735); Death (1802); Hemorrhage/Bleeding (1888); Sepsis (2067); Urinary Tract Infection (2120); No Information (3190); Skin Infection (4544)

Event Date 11/02/2020

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.No additional information was provided.Privacy laws prohibit the customer from providing information regarding the case.No autopsy was performed.The device was not explanted.

Manufacturer Narrative

Section d4, h4: additional information.Section g3: correction.Manufacturer's investigation conclusion: a direct correlation between the reported patient outcome and the heartmate 3 left ventricular assist system (lvas), serial number (b)(4), could not conclusively be determined through this investigation.As privacy laws prohibit the customer from providing information regarding the case, no other information was provided.Heartmate 3 lvas, serial number (b)(4), was not explanted.No product is available for investigation.The heartmate 3 left ventricular assist system instructions for use, lists the adverse events that may be associated with the use of the heartmate 3 lvas, including death.The relevant sections of the device history records for (b)(4) were reviewed.And showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient experienced hypochromic macrocytic anemia requiring a blood transfusion on (b)(6) 2020.The patient's international normalized ration (inr) was 1.74 and hemoglobin was 6.8 g/dl.A colonoscopy and a gastroscopy did not reveal a source of bleeding.A driveline infection and a urinary tract infection led to sepsis despite antibiotics and the patient expired on (b)(6) 2020.

Manufacturer Narrative

Updated manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number:(b)(6), and the reported bleeding, infections, and patient outcome could not be conclusively established through this evaluation.A specific cause for the bleeding and infections could not be determined; the infections reportedly led to the sepsis, and the patient ultimately expired.Heartmate 3 left ventricular assist system (lvas), serial number: (b)(6), was not explanted for investigation.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) rev.G, is currently available.In section 1 ¿introduction,¿ this ifu lists the adverse events that may be associated with the use of heartmate 3 lvas, including infection (localized, driveline, pump pocket or pseudo pocket), sepsis, bleeding, and death.Section 6 ¿patient care and management¿ (under "anticoagulation") provides information regarding anticoagulation, including recommended international normalized ratio (inr) values, and the suggested anticoagulation modifications in the event there is a risk of bleeding.This section also contains information on controlling infection.Heartmate 3 lvas patient handbook (rev.C): section 4 ¿living with the heartmate 3¿ provides some instructions on how to prevent infection, including keeping the hands and driveline site clean.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.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: 11065633
• MDR Text Key: 223407864
• Report Number: 2916596-2020-06086
• 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,Followup,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Model Number: 106524INT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death