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

Model Number 106524US

Device Problems Fluid/Blood Leak (1250); Device Difficult to Setup or Prepare (1487)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/20/2024

Event Type  Injury  

Event Description

It was reported that during the implant procedure the apical cuff sutures were loose.The patient was put back on cardiopulmonary bypass (cpb) and the heartmate 3 was stopped and removed from the apical cuff.The apical cuff was re-sutured, and the inflow cannula was filled with heparinized saline while out of apex/cuff.The heartmate 3 was moved back into place and the patient was weaned from cpb.The pump parameters were noted to be within acceptable limits.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of bleeding from the apical cuff site could not be confirmed through this evaluation.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number mlp-(b)(6) and no further related events have been reported at this time.The relevant sections of the device history records for mlp-(b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.Review of the lvad final assembly device history record showed that the cuff lock installed on mlp-(b)(6) passed all inspection and testing steps.The heartmate 3 instructions for use (ifu), rev.C, is currently available.Section 1 of the ifu ¿introduction¿ lists bleeding as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.Section 5, ¿surgical procedures¿ (under ¿preparing the ventricular apex site¿), contains information regarding the preparation of the ventricular apex site, including how to affix the apical cuff to the left ventricle.This section cautions that after the apical cuff has been sewn to the heart, the metal ring on the apical cuff should extend above the felt surface to allow proper engagement and locking with the slide lock of the heartmate 3 left ventricular assist device.This section suggests tying the sutures of the apical cuff tight with 6 to 7 throws on each knot and instructs the user to ensure that apposition between the myocardial tissue and the cuff felt is continuous and sufficiently forceful to prevent bleeding.Furthermore, section 5 states that during the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in an emergency.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that there was brief bleeding until the sutures were tightened.

• 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: 18887462
• MDR Text Key: 337459495
• Report Number: 2916596-2024-01205
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106524US
• Device Lot Number: 10107031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: Black Or African American