MAUDE Adverse Event Report: MEDTRONIC, INC. HEARTWARE HVAD; VENTRICULAR (ASSIST) BYPASS

Device Problem Infusion or Flow Problem (2964)

Patient Problem Thrombus (2101)

Event Date 12/06/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 patient calling with low flow alarms.Patient seen in clinic later same day.Log files sent and patient admitted for suspected thrombus.On (b)(6) 2020 tpa given-incomplete response (b)(6) patient taken to operating room for pump exchange patient with lvad clot requiring emergent pump exchange, patient has been compliant with warfarin and maintained inr as expected.Fda safety report id # (b)(4).

• Brand Name: HEARTWARE HVAD
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 11404244
• MDR Text Key: 234931286
• Report Number: MW5099741
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 78 YR
• Patient Weight: 83