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 Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Sepsis (2067); Virus (2136); Viral Infection (2248); Blood Loss (2597); Epistaxis (4458)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturers investigation is completed.

Event Description

It was reported that patient had a major infection.Patient was stable and oxygenation was adequate (intermittent oxygen < 4l).Regredient elevated renal parameters under moderate volume substitution (at transfer: creatinine levels at 1.1mg/dl; bun levels at 33mg/dl).It was also noted that patient had oral and nasal mucosal bleeding (epistaxis), a gastral petechia (gastroscopy to rule out gastrointestinal bleeding was performed on admission).There was over anticoagulation and international normalized ratio (inr) was 5.3 at admission, bipolar coagulation of epistaxis from ear nose throat department lab on (b)(6) 2020: inr 6.1; quick 12 %, activated partial thromboplastin time (aptt) was 94 sec, hemoglobin of 12.5 g/dl.Patient also tested positive for covid-19 at admission.Patient was discharged on (b)(6) 2020.

Event Description

It was reported that the patient had a sepsis infection related to sars-cov2.Event was not related to left ventricular assist system (lvas).

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported bleeding and covid-19 infection as well as a direct correlation to heartmate 3 lvas, serial number (b)(6), could not conclusively be determined through this evaluation.It was reported that the patient had covid-19 on (b)(6) 2020.The patient was stable, and oxygenation was adequate.The patient had elevated renal parameters under moderate volume substitution.The patient was discharged on (b)(6) 2020.Per additional information, the patient had oral and nasal mucosal bleeding with gastric petechia on 04nov2020.A gastroscopy was performed to rule out gastrointestinal bleeding.The patient¿s anticoagulation international normalized ratio (inr) was 5.3 at admission.They had bipolar coagulation of epistaxis.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump was shipped on 20nov2015.The heartmate 3 lvas instructions for use (ifu) lists bleeding as an adverse event that may be associated with the heartmate 3 left ventricular assist system.This ifu provides information regarding anticoagulation, including the recommended inr values.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: 11143121
• MDR Text Key: 226057178
• Report Number: 2916596-2020-06393
• 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,s
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 106524INT
• Device Lot Number: 6067843
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention