MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

Model Number 106524

Device Problem Partial Blockage (1065)

Patient Problems Death (1802); Thrombus (2101)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

Approximate age of device - 1 year, 6 months.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that on (b)(6) 2018 it was reported that the patient presented in clinic with a recent history of shortness of breath, a 1 liter decrease in flows and heart failure symptoms with elevated pressures on right heart catheterization.A computerized tomography that revealed a chronic thrombus in proximal aspect of outflow cannula.The thrombus was focal as well as circumferential and was narrowing the lumen up to approximately 50%.It was reported that on (b)(6) 2018, the patient expired.No additional information was provided.

Manufacturer Narrative

A 3rd system controller event log from after the outflow revision was submitted which captured the reported pump flow increase from the 2 lpm range to the 4-5 lpm range.Following the increase, the device appeared to be operating as expected.The patient remains ongoing on vad support.No product available for investigation.The surgical procedures section contains information on "preparing the sealed outflow graft." the attaching the sealed outflow graft to the pump section instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.The "de-airing the pump" section 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.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 to serious adverse events such as low left ventricular assist device flow and/or bleeding.The system monitor section describes the pump flow display and the hazard alarms.The ifu states that the low flow hazard alarm will be triggered when pump flow is less than 2.5 lpm and explains that changes in patient conditions can result in low flow.The alarms and troubleshooting section describes the actions to take in the event of a low flow alarm.A review of the device history records, including the sterilization and packaging documentation, found no deviations from manufacturing specifications.The manufacturer is closing the file on this event.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2016.It was reported that the patient presented with a decrease in flows over time (from 4-3 liters) and heart failure symptoms (mild shortness of breath).A log file submitted to the manufacturer's technical services department for analysis appeared to show that the estimated pump flow was trending slightly downward.The patient was admitted for diuresis, and treatment with inotropes (milrinone) was initiated.A right heart catherization performed showed elevate wedge pressures and low flow from the pump.A cta demonstrated chronic thrombus in the proximal aspect of the outflow graft.The images could not conclusively determine whether the thrombus was inside or outside the outflow graft; however, the deposition was focal and circumferential, with narrowing the lumen up to approximately 50%.The pump speed was increased from 5600 rmps to 6000 rpms, flow was at 3.7 lpm and there was no change in pump power consumption.Laboratory test results and lactate dehydrogenase values were normal.On (b)(6) 2018, the patient was taken to the operating room to assess the outflow graft via a small thoracotomy.It was noted that this procedure was the fourth time the patient was undergoing a re-do sternotomy.The surgeon disconnected the bend relief and turned the outflow graft which immediately resulted in an increase in flow from 2.7 lpm to 4.7 lpm.The bend relief was replaced after tightening the graft and the patient remained stable.No further information was provided.

Manufacturer Narrative

It was incorrectly reported that the patient expired.The patient remains ongoing on vad support.Abbott 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.No further information is available.A supplemental report will be submitted when the manufacturer's investigation is completed.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 7546927
• MDR Text Key: 109354194
• Report Number: 2916596-2018-02118
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2018
• Device Model Number: 106524
• Device Catalogue Number: 106524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 10/26/2018; 11/08/2018
• Supplement Dates FDA Received: 11/01/2018; 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1774-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 63