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

Model Number 106524INT

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturers investigation is completed.

Event Description

It was reported that the patient underwent a heartware ventricular assist device (hvad) to heartmate 3 (hm3) pump exchange on 14sep.The bend relief did not look fully engaged with outflow graft during implant surgery.Pictures were taken during this procedure to document the steps- upon reviewing the pictures it was noted that the bend relief did not look fully engaged with outflow graft during implant surgery.At present, the patient was stable, extubated and doing well.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the submitted photos confirmed the reported outflow graft bend relief disconnect.A specific cause for this finding could not conclusively be determined through this evaluation.It was reported that review of the photos taken during the implant of heartmate 3 left ventricular assist system (lvas), serial number (b)(6), on 14sep2021 noted that the outflow graft bend relief did not appear to be fully engaged to the graft attachment hardware.It was recommended that baseline x-rays in the lateral and frontal positions be taken to confirm the bend reliefs current position.Further x-rays would need to be taken to evaluate any gap or detachment.It was also recommended that a subcostal incision could be made to check the bend relief; however, the reoperation will not be performed, and the patient is stable and extubated.The submitted photos showed that the outflow graft bend relief was not fully secured to the outflow graft hardware.A specific cause for this finding could not conclusively be determined through this evaluation.The patient remains ongoing on heartmate 3 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 lvas kit was shipped on 29jun2021.The heartmate 3 lvas ifu and the heartmate 3 patient handbook are currently available.Section 5 of the ifu, "surgical procedures" (under "preparing the sealed outflow graft"), contains information on how to prepare the sealed outflow graft for implant.Section 5, under ¿de-airing the pump¿, explains that when de-airing is completed, slide the bend relief over the metal fitting of the sealed outflow graft toward the locking screw ring until it engages into place.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 lead to serious adverse events such as low left ventricular assist device flow and/or bleeding.This section then 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 of the ifu, under "securing the pump and connections", cautions that care should be taken to ensure that the sealed outflow graft bend relief remains connected during sternal closure.The ifu instructs that once the flow through the blood pump is satisfactory, ensure that the sealed outflow connections are dry and secure.Obtain hemostasis and close all wounds in the standard fashion.Furthermore, the hm3 patient handbook instructs the user to call their hospital contact if the user thinks, for any reason, any portion of the equipment is not functioning as usual, is broken, or the user is uncomfortable with the operation of the equipment.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 (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: 12567316
• MDR Text Key: 274442230
• Report Number: 2916596-2021-05444
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2022
• Device Model Number: 106524INT
• Device Lot Number: 7955149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 12/07/2021
• Supplement Dates FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• 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 Sex: Male
• Patient Weight: 82 KG