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

Model Number 106524US

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Transient Ischemic Attack (2109); Insufficient Information (4580)

Event Date 05/20/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient underwent heart transplantation.The patient was reportedly upgraded on the list due to past transient ischemic attack (tia) during a previous hospitalization.The device operated as expected and will not be returned for analysis.

Manufacturer Narrative

The patient's previous hospitalization for a transient ischemic attack which upgraded them on the transplant list was reported under mfr# 2916596-2022-11686.Manufacturer's investigation conclusion: a direct correlation between the device and the reported event could not be conclusively established through this evaluation.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) is currently available.Section 1, "introduction," lists other neurological event (not stroke-related) as an adverse event which may be associated with the use of heartmate 3 lvas.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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14647844
• MDR Text Key: 294517027
• Report Number: 2916596-2022-11279
• 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,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7854723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2021
• 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
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 91 KG