MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; Ventricular (assist) bypass

Model Number 106524US

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during pump implant, there was an issue with the apical cuff attachment.When the surgeon attempted to attach, they noticed that the locking mechanism was too easily pushed in to engage with the apical cuff without the customary clicking when the lock is properly engaged.The pump was able to spin 360 degrees freely although the yellow line was not visible.The surgeon decided to remove the pump and retry engaging the purple lock.They used the unlocking hand tool for removal correctly and tried reseating the pump and engaging the lock.After doing so, the surgeon experienced the same issue.The surgeon requested that the backup pump was opened and primed.Before priming the pump, the team tried to see if the same thing would happen if they used the apical cuff from the backup kit.The same issue occurred with the backup apical cuff.The surgeon moved forward with priming the backup pump and was able to attach it to the apical cuff in the patient without any issues.Additional information confirmed that the patient did not experience any adverse effects and was recovering from implant.

• 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: 18749122
• MDR Text Key: 336775591
• Report Number: 2916596-2024-00852
• Device Sequence Number: 1
• Product Code: DSQ
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 106524US
• Device Lot Number: 9252450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White