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

Model Number 106524INT

Device Problems Infusion or Flow Problem (2964); No Apparent Adverse Event (3189)

Patient Problems Dyspnea (1816); Fainting (1847); Hemorrhage/Bleeding (1888); Blood Loss (2597); Syncope/Fainting (4411); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that patient had bleeding and was transferred to the hospital on the same day that patient visited a nearby er (emergency room) due to low flow alarm and fainting.Patient was hospitalized and had blood transfusion.It was noted that bleeding came from the chest, with symptoms of dyspnea.Diagnostic and plan of care was not shared by the center.The device operated as expected, the low flow alarms were noted as likely to be due to the bleeding.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of low flow alarms was not able to be confirmed as no log files were submitted for evaluation.According to the account, the reported low flow alarm was due to bleeding from the chest.A direct correlation between (b)(6), and the patient¿s bleeding could not conclusively be determined.The patient remains ongoing on heartmate 3 left ventricular assist system, serial number (b)(6).No further related events have been reported at this time.The relevant sections of the device history records for (b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) explains that the low flow hazard alarm will be triggered when pump flow is less than 2.5 lpm and notes that changes in patient conditions can result in low flow.This ifu also describes all system alarms and the recommended actions associated with them.It also lists adverse events that may be associated with the use of the heartmate 3 left ventricular assist system, including bleeding, and provides information regarding anticoagulation, including recommended international normalized ratio (inr) values.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

This event was determined to be a duplicate to mfr # 2916596-2021-02239.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 11167565
• MDR Text Key: 227521737
• Report Number: 2916596-2021-00151
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2022
• Device Model Number: 106524INT
• Device Catalogue Number: 106524US
• Device Lot Number: 7573487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention