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

Model Number 106524US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Cardiogenic Shock (2262)

Event Date 07/22/2022

Event Type  Death  

Event Description

It was reported that during an implant, the surgeon noted some bleeding which was believed to be coming from the inflow cannula/ mini apical cuff interface.The patient had a preoperative platelet count of 81 that indicated there could be surgical bleeding.The bleeding was improved, chest was closed and the patient was transferred to the intensive care unit (icu).The patient was returned to the operating room (or) twice for chest exploration for bleeding but cardiothoracic surgery only needle hole bleeding.The patient went into cardiogenic shock that led to multisystem organ failure.In the evening of (b)(6) 2022,the family made a do not resuscitate (dnr) and the patient expired.

Manufacturer Narrative

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

Manufacturer Narrative

Section h6: health effect - clinical code: multiple organ dysfunction syndrome (3261).Manufacturer's investigation conclusion: no device-related issues were identified during evaluation of heartmate 3 lvas, (b)(6).The reported bleeding between the interface of the pump and the apical cuff could not be confirmed as no images were submitted for review, and a direct cause for the reported event was unable to be determined through this evaluation.A direct relationship between the pump and the reported bleeding, cardiogenic shock, multi organ failure, and patient outcome could not be conclusively determined through this evaluation.(b)(6)w as returned assembled with the pump cable severed approximately 20 inches from the pump header and the distal segment was not returned.The modular cable was not returned.The sealed outflow graft attachment was returned attached to the pump cover outlet port.The sealed outflow graft bend relief was returned attached to the graft hardware.The cuff lock was fully engaged, and the mini apical cuff was returned attached to the cuff lock.Upon disassembly of the returned pump, examination of the blood-contacting surfaces revealed no adhered depositions or thrombus formations that would have contributed to a flow or functional issue.Visual inspection of the pump rotor and rotor well did not reveal any obvious surface scratches or defects.Examination of the cuff lock found no evidence of defect or damage.Dimensional analysis of the cuff lock arms, apical sealing ring, motor cap, and the mini cuff found the components to be within manufacturing specification.The cuff lock and apical sealing ring were reassembled, and the mini apical cuff was connected and engaged without issue.The lvad event and periodic log files retrieved from the returned device appeared to capture the device functioning as intended.(b)(6) was cleaned, rebuilt, and functionally tested on a mock circulatory loop.The device operated as intended and in accordance with manufacturing specifications the relevant sections of the device history records were reviewed, including the cuff lock installation and inspection, and showed no deviations from manufacturing or quality assurance specifications.Review of the lvad assembly device history records showed that the cuff lock installed on (b)(6) passed all inspection and testing.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.The ifu lists bleeding, multiple organ failures, and death as adverse events that may be associated with the use of the heartmate 3 lvas.The ifu provides instructions on all surgical procedures, including preparing the ventricular apex site and inserting the pump in the ventricle.The ifu cautions that after the mini apical cuff has been sewn to the heart, the metal ring on the mini apical cuff should extend above the felt surface to allow proper engagement and locking with the slide lock of the heartmate 3 lvad.If the slide lock mechanism on the heartmate 3 lvad fails to engage, do not make further attempts to engage until retracting the slide lock mechanism.Evidence of slide lock mechanism failing to engage will be either visual evidence of the yellow ¿wings¿ or a tactile feel of three ridges versus one.The slide lock will not engage the mini apical cuff unless initially fully retracted.If difficulty persists when engaging the slide lock mechanism, the lvad should be removed from the mini apical cuff to visualize what might be preventing the connection.The suture knots should not interfere with the connection.If a sealing agent is used on or near the mini apical cuff, it should not interfere with the slide lock mechanism.The surgical procedures section also includes information on de-airing the pump.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.

Manufacturer Narrative

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: 15133208
• MDR Text Key: 296908175
• Report Number: 2916596-2022-12615
• 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: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/12/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8495403
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2022
• 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; Hospitalization; Death
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White