MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 106524INT

Device Problem Partial Blockage (1065)

Patient Problems Thrombus (2101); Complaint, Ill-Defined (2331)

Event Date 10/07/2017

Event Type  Death  

Manufacturer Narrative

Fda approval for heartmate 3 lvas was received on 23 august 2017.(b)(4).Approximate age of device ¿ 9 days.The device was not explanted from the patient and therefore is not expected to be returned for evaluation.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported that approximately 9 days after implantation, the patient experienced a low flow situation down to 0.0 l/min in the intensive care unit.The patient was hemodynamically unstable and required administration of catecholamine medications.The patient was returned to the operating room and a pump exchange was performed.During the procedure, the surgeon noted an inflow cannula obstruction by a piece of tissue.No additional information was provided.

Manufacturer Narrative

Device evaluation: no device-related issues were discovered during the evaluation of the returned pump.Review of the submitted system controller and lvad log files as well as the log file data retrieved from returned pump confirmed the report of low flow events down to 0 l/min; however, the evaluation of the returned pump could not determine a specific cause for the low flow situation.The evaluation did not confirm the report of an inflow cannula obstruction by a piece of tissue observed upon explant of the device and no photographs were provided by the user facility.Based on the analysis of the log file data, the pump appeared to be operating as intended.The estimated flow values remained stable in the range of approximately 4.5 l/min to 5.5 l/min since the date of implant on (b)(6) 2017.However, beginning on (b)(6) 2017 at 1:44 am, the estimated flow values dropped down to 0 l/min (below the low flow threshold of 2.5 l/min), resulting in low flow hazard alarms.The low flow hazard alarms continued for the remainder of recorded data until the driveline was disconnected at 2:10 am.When the pump was connected to the backup system controller, the low flow hazard alarms continued and the estimated flow values did not rise above 1 l/min.The pump speed remained above the low speed limit during the low flow events.The pump was returned assembled with the pump cable severed approximately 9 inches from the pump housing.The modular cable and the severed portion of the pump cable were not returned.The sealed outflow graft was returned detached from the pump outflow and the sealed outflow graft bend relief was returned disengaged from the graft attachment.The cuff lock was retracted and the apical cuff was not returned.Upon disassembly of the returned device, visual inspection of the smooth and textured blood-contacting surfaces revealed a small amount of post-explant blood in the inflow cannula, outflow graft, rotor well, and one of the rotor vanes.The evaluation found no evidence of any developed depositions or thrombus formations.Visual inspection of the pump rotor and rotor well did not reveal any surface scratches or defects.Examination of the returned portion of the pump cable found it to be unremarkable.The pump was cleaned, reassembled, and operated on a mock circulatory loop.The device functioned as intended and in accordance with manufacturing specifications.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• 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 ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 6998670
• MDR Text Key: 90935256
• Report Number: 2916596-2017-02579
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: 106524INT
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention