MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSIST) BYPASS

Model Number UNK-PUMP

Device Problems Failure to Pump (1502); Pumping Stopped (1503); Pumping Problem (3016)

Patient Problems Hemolysis (1886); Thrombosis (2100); Malaise (2359)

Event Type  Injury  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy 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.Product event summary: one (1) pump and one (1) controller with unknown serial numbers were not returned for evaluation.The reported high power event was not confirmed via review of the controller log files since log files covering the reported event date were not available for analysis.Of note, it was reported that the patient was treated with tpa and the treatment was unsuccessful.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on historical review of similar high power events, the most likely root cause of the high power event can be attributed to external factors such as thrombus formation/ingestion.Based on the available information, a possible root cause of the pump failing to restart may be attributed to the thrombus ingested inside the pump.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.Additional products: brand name: heartware ventricular assist system ¿ controller, device model #: unk- controller / catalog #: unk - controller / expiration date: unk / serial or lot#: unknown udi #: (b)(4).Device available for evaluation? no.Device manufacture date: unk, labeled for single use? no.(b)(4).This event was reported in the intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was admitted to the hospital with malaise, hemolysis, and high watt alarms.The patient was treated with heparin and had a total of three doses of tissue plasminogen activator (tpa).The treatment was unsuccessful to break the clot.The patient was not a candidate for pump exchange due to right ventricle failure and prior stroke.The patient had a power spike greater than 25 and a subsequent pump failure.The controller was exchanged but the pump failed to restart.The patient was made ¿comfort measures only¿.The controller and ventricular assist device (vad) remain in use.No further patient complications have been reported as a result of this event.This event was reported in the intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8554629
• MDR Text Key: 143227903
• Report Number: 3007042319-2019-06230
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2019

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: Lay User/Patient
• Device Model Number: UNK-PUMP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/26/2019
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 26 YR
• Patient Weight: 64