MAUDE Adverse Event Report: HEARTWARE HEARTWARE; LEFT VENTRICULAR ASSIST DEVICE

Device Problem Device Issue (2379)

Patient Problems Death (1802); Thrombus (2101)

Event Date 11/19/2017

Event Type  Death  

Event Description

Acute hemorrhagic stroke while on tpa infusion for lvad thrombus.Admitted on (b)(6) 2017 for vad thrombus and treated with tpa.On (b)(6) 2017, she had a change in her mental status and a ct of head demonstrated acute left frontal lobe hemorrhage.On (b)(6) 2017 she has had worsening of the brain hemorrhage and midline shift.

• Brand Name: HEARTWARE
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): HEARTWARE; 500 old connecticut path; framingham MA 01701
• MDR Report Key: 7096722
• MDR Text Key: 94207092
• Report Number: 7096722
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Other Device ID Number: LOG#884012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2017
• Distributor Facility Aware Date: 11/15/2017
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 54 YR
• Patient Weight: 68