MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC HEARTWARE LVAD; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number HEARTWARE

Device Problem Obstruction of Flow (2423)

Patient Problems Headache (1880); Failure of Implant (1924); Dizziness (2194); Thrombosis/Thrombus (4440)

Event Date 09/27/2022

Event Type  Injury  

Event Description

Heartware lvad pump outflow graft obstruction and pump thrombus.Hpi: (b)(6) is a 61 y.O.Female with stage d systolic hf 2/2 nicm (adriamycin-induced) s/p heartware lvad (b)(6) 2018.Her post-implant course was notable for worsening tangential behavior for which she has been listed as status 7 and then delisted (b)(6) 2018.She presented to er on "(b)(6)" for evaluation of intermittent low flows.She'd been having low flow alarms since "(b)(6)" despite increasing fluid intake and holding diuretics.She had a ct cardiac morphology which showed narrowing of the outflow cannula and reported intermittent lightheadedness and occasional headache when a low flow is occurring.She was admitted to the cticu for a ramp study and monitoring.Following this her flows dropped precipitously, she was ultimately brought to operating room for urgent pump exchange on (b)(6) 2022.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC HEARTWARE LVAD
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION
• MDR Report Key: 15806929
• MDR Text Key: 303903760
• Report Number: MW5113313
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEARTWARE
• Was Device Available for Evaluation?: Yes
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American