MAUDE Adverse Event Report: HEARTWARE INC. HVAD® PUMP IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 1103

Device Problem Restricted Flow rate (1248)

Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Skin Discoloration (2074); Tachycardia (2095); Thrombosis/Thrombus (4440)

Event Date 09/28/2021

Event Type  Death  

Event Description

Patient presented to ed after consultation with left ventricular assist device (lvad) coordinator due to low flows.He was alert and oriented on my assessment.Pale, fatigued, and nauseated.Intermittently pulsatile.Non-invasive blood pressure mean arterial pressure 84.Wife at bedside.Lvad actively alarming low flow.Connected to monitor.Flow shows abrupt drop in last 12-16 hours, now 0.3.Power now 2.9.Wife states low flows have been present since last preventative maintenance (pm), did not improve with fluids.She did not look at flow value last pm.Patient with history of suspected inlet thrombus 8 months ago.Last in clinic one month ago.Power (w): 4.7 4.9 / 3.6 - 5.5.Of note, controller time and date set to 7 months ago.Unclear why.Wife states no controller exchange.Updated time/date to correct.Sent urgent log file analysis to medtronic.Physicians at bed side at bedside.Suspect recurrence of inlet thrombus.Manufacturer response for lvad pump, (brand not provided) (per site reporter).Unknown.Urgent log file was sent to medtronic.

• Brand Name: HVAD® PUMP IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 13795116
• MDR Text Key: 287336232
• Report Number: 13795116
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 28835 DA
• Patient Weight: 90 KG