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

Catalog Number	1103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Urinary Tract Infection (2120); Blood Loss (2597)
Date of Event	04/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is used for treatment not diagnosis.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.Infection, gastrointestinal bleed are known potential adverse event associated with the implantation of all vads as outlined in the instructions for use.Gastrointestinal bleeding has been identified as a known potential risk associated with use of all vads as outlined in the instructions for use (ifu).Known contributing factors to gi bleeding include individual patient comorbidities and pharmacological factors.The ifu addresses guidelines for optimal patient management, including therapeutic anticoagulation guidelines.Gi bleeding/av ms are known potential complications associated with all patients implanted with vads.With review of the available information there is no indication of any device malfunction or performance issues impacting the event.Although a definitive root cause cannot be determined, clinical, pharmacological, and patient factors including comorbidities are known possible contributors to the event.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.Device remains implanted.
Event or Problem Description
It was reported from the clinical study site that the patient was admitted on (b)(6) 2017 for upper gastrointestinal (gi) bleeding and bacteria gi infection with a urinary tract infection.Patient was stated to have been transfused 5 units of packed red blood cells (prbc's).Patient was also stated to have received angiectasia clipping, medication management, and antibiotics.Patient was stated to have been discharged on (b)(6) 2017.No additional information available.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Common Device Name: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• MDR Report Key: 6684065
• Report Number: 3007042319-2017-02059
• Device Sequence Number: 2059764
• Product Code: DSQ
• UDI-Device Identifier: 00888707000062
• UDI-Public: 00888707000062
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 111