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

Device Problems Increase in Suction (1604); Pumping Problem (3016)

Patient Problems Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Product event summary: a pump with unknown serial number was not returned for evaluation.The reported low flow event was not confirmed via review of the controller log files since log files covering the reported event date were not available for analysis.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on risk documentation, multiple factors may have contributed to the low flow event including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, inappropriate pump rotational speed.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 2020 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.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was hospitalized due to the ventricular assist device (vad) exhibiting constant low flow alarms and the patient experiencing nausea and chest pain.Vad interrogation revealed low to no vad flow and a vad stoppage.The vad was suspected to have a thrombus and the patient experienced heart failure.The patient was started on intravenous heparin and had their coumadin held.The patient had an intra-aortic balloon pump and a pulmonary artery catheter placed.The patient was put on a vasodilator and was later weaned off.A computerized tomography (ct) angio vad study did not reveal thrombosis or kinking.It was suspected that the low flows were due to possible temporary vad suction or kinking.The patient¿s coumadin was restarted with a heparin bridge and once the international normalized ratio (inr) was in therapeutic range, the heparin was discontinued.The vad parameters remain stable and the patient was discharged on coumadin, persantine, and aspirin.The vad remains in use.No further patient complications have been reported as a result of this event.This event was reported in the q3 2020 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11324592
• MDR Text Key: 232332742
• Report Number: 3007042319-2021-01493
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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: 01/14/2021
• 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: 69 YR
• Patient Weight: 52