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

Model Number 106524US

Device Problems Decreased Pump Speed (1500); Infusion or Flow Problem (2964)

Patient Problems Syncope/Fainting (4411); Unspecified Respiratory Problem (4464)

Event Date 03/14/2024

Event Type  Injury  

Event Description

It was reported that the patient found unresponsive, in respiratory distress.Log files were submitted for review and noted that there was a slight dip in flow and pump power on 21mar2024 at 01:06 through 01:10.Flow was noted in the 4 range slightly below baseline and pump powers were in the high 3w range with a baseline of 4w.These were not sustained but notable on the event log graph.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Manufacturer Narrative

Section d1: corrected.Section d4, catalog number, primary udi number: corrected.Section h6, health effect - clinical code: corrected.Section h6, medical device problem code: corrected.Manufacturer¿s investigation conclusion: a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), and the reported event could not be conclusively established through this evaluation.A review of the submitted log files revealed that the device was operating as expected at the set speed.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No further issues 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 lvas instructions for use (ifu) is currently available.Section 1 of the ifu, ¿introduction¿, lists the adverse events, including respiratory failure, that may be associated with the use of the heartmate 3 left ventricular assist system.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 (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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 19117489
• MDR Text Key: 340291697
• Report Number: 2916596-2024-02180
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: (01)00813024013297(10)8668229(17)240613
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106524US
• Device Lot Number: 8668229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/17/2022
• 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): Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 112 KG