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

Model Number 106524US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arrhythmia (1721)

Event Date 07/18/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(4), and the reported events could not be conclusively determined through this evaluation.The controller event log file contained data from 16jul2022 through 18jul2022.No notable events or alarms were captured, and the pump appeared to function as intended at the set speed.The patient remains ongoing on hm3 lvas, serial number (b)(4), and no further events have been reported at this time.The hm3 lvas ifu, rev.C, is currently available.The ifu, ¿introduction¿, lists cardiac arrhythmia as a potential adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.The ifu, ¿patient care and management¿, lists arrhythmia as a potential late postimplant complication.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 01aug2019.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient was admitted on (b)(6) 2022 after arrhythmia.Liable pulsatility index (pi) events were noted.Log file review did not capture any unusual events.The patient was on an antiarrhythmic drip.

• 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: 15115211
• MDR Text Key: 296719730
• Report Number: 2916596-2022-12422
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2022

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/17/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7077506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 125 KG