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

Model Number	HVAD PUMP 1103
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Death (1802); Hemolysis (1886); Hematuria (2558)
Date of Event	01/29/2019
Type of Reportable Event	Death
Event or Problem Description
This pt has a heartware lvad (implanted (b)(6) 2015, and (b)(6) 2016).Pt presented to the emergency dept on (b)(6) 2019 for increased lvad power.He reports dark colored urine that developed recently as well as noticing increasing voltage on his lvad from a baseline of 7 to over 9 volts.After admission he was started on high dose heparin per lvad thrombus protocol.Integrilin was not given due to thrombocytopenia.Ct surgery was consulted and did not feel he would be a candidate for any intervention or lvad exchange given his poor tolerance of his last exchange and multiple comorbidities.He was put in a nicardipine drip for control of his bp with anticoagulation.Hematology was consulted with regards to his polycythemia and felt it was most likely secondary to chronic hypoxemia.He continued to hemolyze and did not improve on heparin alone, so he was given a dose of tpa, which resulted in some improvement in his lvad wattage from 9 to approx 7.7.However, he became anuric and developed acute renal failure.He met with the palliative team and made it clear he did not want dialysis.After some discussion with his son, he decided to go home on hospice given that he had limited future options for dealing with the lvad thrombus.Arrangements were made for home hospice and he was discharged home on (b)(6) 2019.On (b)(6) 2019 the pt passed away at home in the setting of acute renal failure.Mcs device related sae.

• Brand Name: HEARTWARE HVAD
• Common Device Name: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 8433084
• Report Number: 8433084
• Device Sequence Number: 1019817
• Product Code: DSQ
• UDI-Device Identifier: 00888707000062
• UDI-Public: 00888707000062
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/01/2019
• Report Date (Section F): 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: HVAD PUMP 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/29/2019
• Device Age: 33 MO
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC CRT-D
• Outcome Attributed to Adverse Event: Death
• Patient Age: 66 YR
• Patient Weight: 121