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

Device Problem Pumping Problem (3016)

Patient Problems Hemolysis (1886); Thromboembolism (2654); Thrombosis/Thrombus (4440)

Event Date 01/01/2021

Event Type  Injury  

Event Description

It was reported that the patient was admitted with ventricular assist device (vad) power elevations, increasing lactate dehydrogenase (ldh), and imaging suggestive of aortic valve thrombus.It was reported that the patient had subtherapeutic anticoagulation.Despite medical therapy, the vad power consumption and patient's ldh continued to increase.The patient also had an arterial non-cns thromboembolism that was diagnosed via standard clinical and laboratory testing.The patient received a vad exchange.No further patient complications were reported as part of the event.This event was reported in the q3 2021 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.

Manufacturer Narrative

Product event summary: a pump with unknown serial number was 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.Based on the limited information available, the device may have caused or contributed to the reported event.Based on the available information and historical review of similar high power events, the most likely root cause of the high power event may be attributed to thrombus formation/ingestion.Per the instructions for use, this event is a known potential complication associated with the implantation of a vad.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.This event was reported in the q3 2021 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.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
• Type of Device: VENTRICULAR (ASSISST) 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13467105
• MDR Text Key: 288700176
• Report Number: 3007042319-2022-02269
• 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: 02/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2022
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 138 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White