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

Model Number 1103

Device Problems Complete Blockage (1094); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/22/2021

Event Type  Injury  

Event Description

This event report is being filed so that appropriate filing can be performed to the fda.It is a device thrombus, not related to patient noncompliance or to any mistakes made by any staff or medical team members during patient's admission to ed or in subsequent hospitalization.Patient arrived at emergency department with complaints of a grinding sound from his lvad and low-flow alarms.He had reported some recent bouts of diarrhea.Lvad coordinator downloaded the lvad logfile, which was analyzed by medtronic.Of note, there were no increases in power or increases in flow that would have indicated a thrombus.Also, inr was 2.2 and had been therapeutic for a month.No thrombus was noted per echocardiogram.A ct with contrast was deferred due to patient's renal status.Patient was admitted and put on a heparin drip.Ldh was 345 one week earlier and had risen to 455, peaking to 1522 three days later, then slowly declining to 356 two weeks later.Haptoglobin remined low at 12, and max level was 18.Patient was placed on a milrinone drip and listed as status 2 for transplant due to device malfunction.He received heart transplant two weeks after initial ed visit.Plan to return lvad to manufacturer for analysis.Manufacturer response for lvad, heartware (per site reporter).

Event Description

This event report is being filed so that appropriate filing can be performed to the fda.It is a device thrombus, not related to patient noncompliance or to any mistakes made by any staff or medical team members during patient's admission to ed or in subsequent hospitalization.Patient arrived at emergency department with complaints of a grinding sound from his lvad and low-flow alarms.He had reported some recent bouts of diarrhea.Lvad coordinator downloaded the lvad logfile, which was analyzed by medtronic.Of note, there were no increases in power or increases in flow that would have indicated a thrombus.Also, inr was 2.2 and had been therapeutic for a month.No thrombus was noted per echocardiogram.A ct with contrast was deferred due to patient's renal status.Patient was admitted and put on a heparin drip.Ldh was 345 one week earlier and had risen to 455, peaking to 1522 three days later, then slowly declining to 356 two weeks later.Haptoglobin remained low at 12, and max level was 18.Patient was placed on a milrinone drip and listed as status 2 for transplant due to device malfunction.He received heart transplant two weeks after initial ed visit.Plan to return lvad to manufacturer for analysis.Manufacturer response for lvad, heartware (per site reporter).Unknown.

• Brand Name: HVAD PUMP IMPLANT KIT
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 12300579
• MDR Text Key: 265817247
• Report Number: 12300579
• 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
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 17885 DA
• Patient Weight: 110