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 Stroke/CVA (1770); Death (1802); Thrombus (2101)

Event Date 10/20/2017

Event Type  Death  

Manufacturer Narrative

Fda approval for heartmate 3 lvas was received on 23 august 2017.(b)(4.Approximate age of device ¿ 1 year and 7 months.Section f10: multi organ failure 3261.He device is expected to be returned for analysis.It has not yet been received.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) 2016.It was reported that the patient was admitted to the hospital on (b)(6) 2017 due to a worsening of the patient''s general condition.An evaluation revealed the beginning of multi organ failure as a sign of low cardiac output.The lvad system was reportedly working as expected; however, there was a reduction in the calculated pump flow over the last 7 days.A transthoracic echocardiogram showed good positioning of the inflow cannula as well as good filling of the left ventricle.A ct scan showed no kinking or obstruction in the visible area.A system controller log file analysis by the manufacturer¿s technical service representative confirmed the reduction of pump flow from about 5 lpm to 3 lpm.The patient was stabilized.Pressure measurements inside the outflow graft showed that pressure in the outflow graft was unexpectedly lower than in the outflow elbow of the pump.On (b)(6) 2017, the patient again showed signs of low cardiac output.The patient was returned to the or and a surgical examination revealed a compression of the outflow graft underneath the bend relief.The compression was caused by a fibrin like structure directly at the beginning of the outflow graft.The surgeon removed the structure and the lvad flow went back to 5 lpm.The patient subsequently expired on (b)(6) 2017 due to subarachnoid bleeding.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.The report of a compression of the outflow graft underneath the bend relief could not be confirmed through this evaluation.Evaluation of the submitted log files confirmed a gradual decrease in flow over time; however, no hazard alarms were captured and the pump appeared to function as intended.A correlation between the device and the reported subarachnoid bleeding could not be conclusively determined; however, stroke and bleeding are listed in the instructions for use as potential adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.The manufacturer is closing the file on this event.

Manufacturer Narrative

Abbott has decided to initiate a voluntary field action for all lot numbers of heartmate iii distributed since september 2014.Internal investigation performed by abbott has determined there is a potential for an outflow graft occlusion due to twisting.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.The root cause identification determined that bend relief rotation is inconsistently translated to the outflow graft hardware.A risk/benefit analysis was performed and it was determined that despite the potential for an outflow graft occlusion due to twisting, the associated residual risks are low and are considered acceptable.As a corrective action, consignees have been notified of the potential occlusion due to twisting.Additionally, abbott will continue to trend complaints related to this event based on original event description and/or results of product evaluation.

• 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: 7029484
• MDR Text Key: 91959449
• Report Number: 2916596-2017-02738
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 106524INT
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/14/2017
• Supplement Dates Manufacturer Received: 02/19/2018; 03/22/2018
• Supplement Dates FDA Received: 02/27/2018; 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-1774-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 125