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

Model Number 106524US

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2020

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 detachment of the bend relief of the outflow graft was confirmed through x-ray.No twisting of the outflow graft was observed.No altered hemodynamics were reported.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported detachment of the outflow graft bend relief from the outflow graft could not be confirmed through this evaluation as no photos were submitted and the device was not returned.Additionally, a specific cause for the disconnection could not be conclusively determined.It was reported that on (b)(6) 2020, an x-ray was performed which revealed detachment of the outflow graft bend relief.No twisting of the outflow graft was observed, and there was no information regarding any effect on hemodynamics noted.The patient reportedly underwent re-thoracotomy and had the bend relief attached.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6).No product is available for investigation.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 5 contains information on "preparing the sealed outflow graft." "de-airing the pump" explains that when the pump is in place and the sealed outflow graft anastomoses is completed, residual air must be completely evacuated from the device blood chamber prior to initiating device activation.When de-airing is completed, slide the bend relief over the metal fitting of the sealed outflow graft toward the locking.This section warns that failure to connect the bend relief so that it is fully and evenly connected can allow kinking and abrasion of the graft, which may to serious adverse events such as low left ventricular assist device flow and/or bleeding.Next, this section of the ifu instructs the user to visually inspect the bend relief to confirm that it is fully connected and seated to the sealed outflow graft.To confirm, try to unseat the connected bend relief from the metal fitting by gently pulling the bend relief back toward the anastomosis and then towards the pump.The bend relief should remain captured and move approximately 0.5 mm without disengaging from the graft.Section 5 also cautions that care should be taken to ensure that the sealed outflow graft bend relief remains connected during sternal closure.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient underwent re-thoracotomy and had the bend relief attached.The patient did not experience any consequences.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) 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: 12887725
• MDR Text Key: 282974399
• Report Number: 2916596-2021-06919
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/09/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7104648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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 Age: 46 YR
• Patient Sex: Male
• Patient Weight: 69 KG