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

Model Number 1103

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemolysis (1886); Hematuria (2558)

Event Date 08/05/2017

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.This event was assessed and is being reported as part of a retrospective review of log file data.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was suspicion for hemolysis with significant hematuria.The ventricular assist device (vad) remains implanted.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

(b)(4).The pump was not returned for evaluation.Review of controller log files revealed 7 low flow alarms logged between (b)(6) 2017 and (b)(6) 2017.Intermittent suction events were also observed, with 41 suction alarms logged since (b)(6) 2017.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the risk documentation, possible causes of the low flow and suction events may be attributed to multiple factors including but not limited to thrombus at the inflow cannula, inappropriate pump rotational speed, poor vad filling.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.Thereare possible patient, pharmacological and procedural factors that may have contributed to this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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
• MDR Report Key: 7710411
• MDR Text Key: 114709674
• Report Number: 3007042319-2018-03183
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000017
• UDI-Public: 00888707000017
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2019
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR