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U.S. Department of Health and Human Services

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

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HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM- PUMP CIRCULATORY ASSIST SYSTEM, Back to Search Results
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
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.
 
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.
 
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Brand NameHEARTWARE® VENTRICULAR ASSIST SYSTEM- PUMP
Type of DeviceCIRCULATORY 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 Key6597341
MDR Text Key106283648
Report Number3007042319-2017-01633
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
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 Received05/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2017
Device Catalogue Number1103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/30/2017 Patient Sequence Number: 1
Treatment
(B)(4)/CONTROLLER
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