MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM- PUMP; CIRCULATORY ASSIST SYSTEM,

Catalog Number 1103

Device Problems Restricted Flow rate (1248); Failure to Pump (1502); Pumping Stopped (1503); Obstruction of Flow (2423)

Patient Problems Death (1802); Thrombus (2101)

Event Date 05/12/2017

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: (b)(4)- controller / catalog number: 1403de / expiration date: 03/31/2016; device available for eval: no; device eval by mfr: no, not returned to manufacturer; labeled for single use: no; (b)(4).The ventricular assist system is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.The implantation of a vad is an invasive procedure requiring general anesthesia, median sternotomy, a ventilator and cardiopulmonary bypass.A user must fully consider the risks of this device with that of other treatment modalities before deciding to proceed with device implantation.These surgical procedures are associated with numerous risks.Death and thrombus are known potential adverse event associated with the implantation of all vads as outlined in the instructions for use.High watts alarms, an indication that the pump watts has exceeded the high power alarm threshold, may be indicative of thrombus or other tissue fragments in the pump.Thrombus is a known potential complication associated with all patients implanted with vads as outlined in the labeling.The instructions for use addresses setting parameters for the high power alarm threshold, how to recognize high watt alarms and guidelines for optimal patient management (including therapeutic anticoagulation guidelines).Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Event Description

It was reported from the site that the patient had low flow alarms at home and then presented to the emergency room (er) on (b)(6), then started to have high watt alarms.  patient was not complaining of symptoms but has altered mental status as baseline due to previous stroke.On arrival left ventricular assist device (lvad) history showed low flow of 2.0 with power of 2.7 watts.  there were two suction events at 2347 with flow of 6.0 and powers of 4.7.At 0010 flow increased to 12 with power of 6.1.  the patients ventricular assist device (vad) hum was distortional.  it was stated that the international normalized ratio (inr) on admission was 1.3 and patient was admitted for suspected pump thrombosis.  according to the doctor's note, the patient developed acute pump thrombosis with pump stoppage.Patient was stated to not being a candidate for pump exchange and not a candidate for tissue plasminogen activator (tpa) due to stroke with hemorrhagic conversion.  patient was then placed on heparin and tirofiban early, despite this pump stopped.  patient was placed in hospice for comfort measures and pump was turned off by site.  the patient passed away suddenly during lunch with his family by his side, the next day on (b)(6).It was stated that the cause of death was the primary cardiac event on (b)(6) at 1445.The doctor states it is pump related because of the pump stop.It was further stated that there would be no autopsy.No additional information available.

Manufacturer Narrative

Controller/(b)(4)/ udi# (b)(4), mfr date: 2015-03-31 (b)(4).Controller / (b)(4)/ expire date 2016-04-30/ udi# (b)(4), mfr date: 2015-04-30.(b)(4).Product event summary # (b)(4) were not returned for evaluation.Review of the manufacturing documentation confirmed that the associated devices met all requirements for release.The reported event was confirmed via review of the log files which revealed a sudden decrease in power consumption and estimated flow starting on (b)(6) 2017 followed by an increase in power on (b)(6) 2017.Suction alarms have been logged since (b)(6) 2017.11 low flow alarms have been logged since (b)(6) 2017.13 high watt alarms have been logged since (b)(6) 2017.1 vad disconnect alarm was logged on (b)(4) on (b)(6) 2017 at 07:43:32 likely due to physical disconnection of the driveline from the controller.1 vad stopped alarm was logged on (b)(4) on (b)(6) 2017 at 07:46:02.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the available information, the most likely root cause of low flow alarms and suction events may be attributed to thrombus at the inflow cannula; the thrombus likely got ingested into the pump further triggering high watt alarms and causing the pump to stop.The device remains implanted in the patient and is thus not available for return to the manufacturer.With a review of the available information there is no evidence to indicate any device malfunctions or performance issues that would impact the reported events.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM- PUMP
• Type of Device: CIRCULATORY ASSIST SYSTEM,
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer Contact: anne schilling ; 8200 coral sea street ne; mounds view, MN 55112-3105 ; 7635052036
• MDR Report Key: 6597341
• MDR Text Key: 76132738
• Report Number: 3007042319-2017-01633
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2015
• 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
• Treatment: (B)(4)/CONTROLLER
• Patient Outcome(s): Death