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 Stroke/CVA (1770); Infarction, Cerebral (1771); Encephalopathy (1833); Unspecified Infection (1930); Renal Failure (2041); Sepsis (2067)

Event Date 11/02/2020

Event Type  Injury  

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 that the patient had multi organ issues on (b)(6) 2020 after implantation.When attempting to wean patient from ventilator the patient was not awake nor responsive.Ct scan showed infract's in the brain.Electroencephalogram showed abnormal result suggestive of diffuse encephalopathy.The patient had oliguria, high creatinine levels.Nephrologist put patient on continuous renal replacement therapy on (b)(6) 2020 the patient was found to have high white blood cell count.Urine/endotracheal secretion culture showed candida tropicalls.Treatment included antibiotics and cytosorb filter.On 05nov2020, ct scan showed increased edema of infracts in the brain and a few hemorrhagic densities.Follow-up ct scan on 23nov2020 showed hypodense infract's.The patient is suffering from sepsis.Blood cultures revealed chryseobacterium indigenes.The patient is on ventilator, requiring dialysis for renal failure (the patient had pre-existing mild chronic kidney failure.Pre-implantation creatinine levels were 1.6).There was not much improvement in neurological function.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct relationship between heartmate 3 (hm3) left ventricular assist system (lvas), serial number (b)(6), and the reported multi organ failure, infection, sepsis, and stroke could not be conclusively determined through this evaluation.The patient later expired due to cardiac arrest on (b)(6) 2020 following a ct scan that showed subarachnoid/intraventricular hemorrhage (refer to manufacturer report number # 2916596-2020-06428).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 with heartmate 3 left ventricular assist system (lvas) instructions for use (ifu).Multiple organ dysfunctions/failures, stroke, infection, and sepsis are listed as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.Section 6 provides information regarding anticoagulation, including the recommended inr values.Care instructions in regard to preventing infection are provided in various sections of this ifu, including a section entitled "controlling infection." the heartmate 3 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: 11080256
• MDR Text Key: 224025363
• Report Number: 2916596-2020-06134
• 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: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/11/2022
• Device Model Number: 106524INT
• Device Lot Number: 6935807
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention